Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator6mm Diameter x 2cm Length Balloon Dimension180cm Total Catheter Length
2023-07-12
TeleMed Systems
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1222168 | 1222168 | TeleMed Systems | 1 | N | 2026-01-01 | 44 Bearfoot Rd Ste 200 Northborough MA US 01532 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 282639 | 1637485675 | K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | KNS | 1999-12-22 |
| 282639 | 1980066038 | K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | KGE | 1999-12-22 |
| 282639 | 1838902504 | K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | KNW | 1998-01-21 |
| 282639 | 2042144503 | K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | OCZ | 1997-12-19 |
| 282639 | 1557863474 | K945295 | LSVP INTERNATIONAL GRASPING FORCEPS | LQR | 1995-03-08 |
| 282639 | 1387350926 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | FEB | 1990-06-11 |
| 282639 | 1645693952 | K901438 | SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE | GAA | 1990-05-24 |
| 282639 | 1275423924 | K901437 | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE | FBK | 1990-06-18 |
| 282639 | 1636286251 | K901436 | BRONCHIAL CYTOLOGY BRUSH | FDX | 1990-06-18 |
| 282639 | 2031200990 | K901435 | GASTROINTESTINAL CYTOLOGY BRUSH | FDX | 1990-07-16 |
| 282639 | 1000266885 | K901432 | BILIARY BALLOON DILATOR | FGE | 1990-06-21 |
| 282639 | 1879780567 | K901431 | TELEMED ERCP CANNULA | FGE | 1990-06-18 |
| 282639 | 1730963514 | K901429 | SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE | OCY | 1990-06-05 |
| 282639 | 2057238606 | K901428 | DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE | FDI | 1990-06-18 |
| 282639 | 2046166418 | K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | FGE | 1990-06-22 |
| 282639 | 1941097897 | K901424 | ESOPHAGEAL BALLOON DILATOR | KNQ | 1990-06-21 |
| 282639 | 1860864528 | K020379 | PPD BALLOON DILATATION CATHETER | KNT | 2002-05-06 |
| 282639 | 1983149596 | K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | FGE | 2002-03-01 |
| 282639 | 1488012638 | K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | OCZ | 2001-04-02 |
| 282639 | 1162237879 | ||||
| 282639 | 1238180886 | ||||
| 282639 | 1240824150 | ||||
| 282639 | 1464170935 | ||||
| 282639 | 1506875242 | ||||
| 282639 | 1748756973 | ||||
| 282639 | 1837175512 | ||||
| 282639 | 1996385352 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FGE | 4 | 2002-03-01 |
| OCZ | 2 | 2001-04-02 |
| FDX | 2 | 1990-07-16 |
| KNT | 1 | 2002-05-06 |
| KNS | 1 | 1999-12-22 |
| KGE | 1 | 1999-12-22 |
| KNW | 1 | 1998-01-21 |
| LQR | 1 | 1995-03-08 |
| KNQ | 1 | 1990-06-21 |
| FDI | 1 | 1990-06-18 |
| FBK | 1 | 1990-06-18 |
| FEB | 1 | 1990-06-11 |
| OCY | 1 | 1990-06-05 |
| GAA | 1 | 1990-05-24 |
GUDID#
Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator8mm Diameter x 4cm Length Balloon Dimension180cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Biliary Balloon Dilatation Catheter - Biliary Dilator10mm Diameter x 8cm Length Balloon Dimension180cm Total Catheter Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle21GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 200cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 1.8mm Sheath Diameter x 5mm Needle Length x 230cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle23GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length
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Disposable Sclerotherapy Needle - Sure-Stop Sclerotherapy Needle25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 160cm Working Length
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Disposable Transbronchial Needle - Sure-Stop Transbronchial Aspiration Needle21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 160cm Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 200cm Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 230cm Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 160cm Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 200cm Length
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Disposable Gastrointestinal Cytology Brush - Gastrointestinal Cytology Brush3.0mm Brush Diameter x 2.3mm Catheter Diameter x 230cm Length
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Disposable Bronchial Cytology Brush - Disposable Bronchial Cytology Brush2.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Length
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Disposable Bronchial Cytology Brush - Disposable Bronchial Cytology Brush3.0mm Brush Diameter x 1.8mm Catheter Diameter x 120cm Length
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Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.5mm, 16.5mm, 20.0mm7fr Shaft Size x 200cm Catheter LengthStiff Shaft Style with Distal Injection Port
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Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.5mm, 16.5mm, 20.0mm7fr Shaft Size x 200cm Catheter LengthDistal Injection Port
2023-07-19
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.0mm, 16.5mm, 20.0mm7fr to 5fr Shaft Size x 200cm Catheter LengthProximal Injection Port
2023-07-19
Disposable Duralon Occlusion Balloon - 2 Lumen - Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.0mm, 16.5mm, 20.0mm7fr to 5fr Shaft Size x 200cm Catheter LengthDistal Injection Port
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator8mm Diameter x 8cm Length Balloon Dimensions200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator10mm Diameter x 4cm Length Balloon Dimension200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator10mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12
Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator12mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator14mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator16mm Diameter x 4cm Length Balloon Dimension200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator16mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
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Disposable Sure-Flex Balloon Dilatation Catheter - Esophageal Dilator18mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
2023-07-12