510(k) K885179
- Device
- INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
- Applicant
- BAXTER HEALTHCARE CORP.
- 510(k) number
- K885179
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-09
- Date received
- 1988-12-14
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CORRINE M TAFLINGER
- Address
- P O Box 11150 Santa Ana CA US 92711 92711
FDA Registration Numbers#
- 1000523114
- 1650907
- 2953359
- 3030446844
- 3007882731
- 2648045
- 3006260740
- 3004784537
- 3001124136
- 3009746061
- 3004737415
- 1820334
- 1824619
- 3010391198
- 1000121056
- 3008853977
- 1220477
- 3011564431
- 3020954746
- 1828424
- 3004091615
- 1018470
- 9610825
- 9612164
- 3007695959
- 1313046
- 3013557562
- 3042279517
- 3010966701
- 3032916632
- 3010141307
- 1048735
- 9612086
- 2134812
- 3012179728
- 3016678045
- 3015225571
- 3031983053
- 3011657089
- 3027366703
- 1721504
- 3006082230
- 3001374820
- 1220648
- 3020968442
- 3037050339
- 3043337628
- 3012050423
- 3015138222
- 3011610434
- 3017689643
- 3011024991
- 1224960
- 3022518300
- 3007697249
- 1035166
- 3017567825
- 3038188187
- 1423507
- 3008998256
- 9680794
- 2011171
- 2183870
- 3007207906
- 1722746
- 3017060084
- 3025341484
- 2029015
- 1221019
- 2025816
- 3010055973
- 1526711
- 3003915875
- 9614279
- 3008328690
- 3008514120
- 1424263
- 1450662
- 3011642792
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
Legacy Summary#
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FDA Review#
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