018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical Ltd. Dba Surmodics, Inc.
Creagh Medical Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005994106 | 3005994106 | Creagh Medical Ltd. | 1 | N | 2026-01-01 | IDA Business Park Ballinasloe Co. Galway IE H53 K8P4 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 112049 | 1442695727 | K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | LIT | 2024-11-15 |
| 112049 | 1967476307 | K211044 | Sublime Radial Access 018 RX Dilatation Catheter | LIT | 2021-06-16 |
| 112049 | 1778573353 | K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | LIT | 2020-05-14 |
| 112049 | 1033317737 | K190644 | Guide Sheath | DYB | 2019-04-18 |
| 112049 | 1388241881 | K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | LIT | 2018-04-19 |
| 112049 | 1000584744 | K173560 | Microcatheter | DQY | 2018-01-12 |
| 112049 | 1221665656 | K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | LIT | 2017-09-08 |
| 112049 | 1505690532 | K170635 | Chameleon PTA Balloon Catheter | LIT | 2017-03-30 |
| 112049 | 2018596287 | K143561 | ELM PTA Balloon Dilatation Catheter | LIT | 2015-05-19 |
| 112049 | 1843391318 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 |
| 112049 | 1126546767 | K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER | LIT | 2010-12-10 |
| 112049 | 1027231790 | K082646 | OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER | DQY | 2008-11-03 |
| 112049 | 1819787453 | K072156 | OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER | DQY | 2007-11-09 |
| 112049 | 1393720885 | ||||
| 112049 | 1801685484 |
Product Codes Associated With Registrations#
PMN#
Arise? UHP Dilatation Catheter
Creagh Medical, Ltd.
Sublime Radial Access 018 RX Dilatation Catheter
Creagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics,
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
Creagh Medical Ltd.
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical, Ltd.
014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Creagh Medical
ELM PTA BALLON DILATATION CATHETER
CREAGH MEDICAL LTD
WILLOW/ELM PTA BALLOON DILATATION CATHETER
CREAGH MEDICAL LTD
GUDID#
Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter - 018 Advance Serenity 7x220, 135cm
2025-03-14
Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter - 018 Advance Serenity 6x220, 135cm
2025-03-14
Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter - 018 Advance Serenity 5x220, 135cm
2025-03-14
Telemark™ Microcatheter - The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placementof guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and iscompatible with a 0.014” guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wallthickness and tapers to the distal end. The catheter is available in lengths of 135 cm and 150 cm in length to facilitate access tovarious target sites.
2021-07-08
Telemark™ Microcatheter - The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placementof guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and iscompatible with a 0.014” guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wallthickness and tapers to the distal end. The catheter is available in lengths of 135 cm and 150 cm in length to facilitate access tovarious target sites.
2021-07-08
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 150 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 120 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 100 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 80 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 60 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 40 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 6.0 mm x 20 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 150 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 120 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 100 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 80 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 60 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 40 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 5.0 mm x 20 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 220 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 150 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 120 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 100 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 80 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 60 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 40 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 4.0 mm x 20 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 220 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 150 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 120 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 100 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 80 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 60 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 40 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.5 mm x 20 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.0 mm x 220 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.0 mm x 150 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.0 mm x 120 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.0 mm x 100 mm, 220 cm
2021-10-20
Sublime™ Radial Access 018 RX PTA Dilatation Catheter - 018 Radial RX PTA, 5Fr, 3.0 mm x 80 mm, 220 cm
2021-10-20