510(k) K001367
- Device
- FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
- Applicant
- ST. JUDE MEDICAL, INC.
- 510(k) number
- K001367
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-31
- Date received
- 2000-05-01
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL CORNELISON
- Address
- 14901 Deveau Pl. Minnetonka MN US 55345 55345
FDA Registration Numbers#
- 9612126
- 1319211
- 3030733800
- 3020954746
- 3004091615
- 1223004
- 2518902
- 3001374820
- 3010041511
- 3030446844
- 2134265
- 3006082230
- 3015173212
- 3012050423
- 1450662
- 2527072
- 3010055973
- 2030624
- 3009437315
- 3008114965
- 8043892
- 3025028711
- 3017567825
- 9612433
- 3005168196
- 3012536737
- 3027815
- 1313046
- 1721504
- 9616099
- 3035111606
- 3009211636
- 3031571797
- 2020394
- 1282497
- 2648045
- 1061927
- 1225687
- 3031282706
- 3041276591
- 3016904853
- 1018233
- 3017636737
- 3010200163
- 3007284313
- 3013764800
- 3003915875
- 2953359
- 3016986313
- 3006131984
- 9617604
- 3013557562
- 1625425
- 3020968442
- 1643817
- 1423507
- 3009350690
- 3011137372
- 9681834
- 2090040
- 3008998256
- 3010273872
- 9680794
- 1644312
- 3042279517
- 3010131137
- 1224960
- 3013288201
- 3046772394
- 1054241
- 3043337628
- 1625685
- 2030598
- 3014656749
- 9614279
- 9610825
- 3027366703
- 1649395
- 3015225571
- 2182208
Source Documents#
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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