510(k) K230704
- Device
- RAIN Sheath? Tibial Pedal Introducer
- Applicant
- Cordis US Corp
- 510(k) number
- K230704
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-24
- Date received
- 2023-03-14
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Wai Morgan
- Address
- 14201 NW 60th Ave. Miami Lakes FL US 33014 33014
FDA Registration Numbers
- 1722746
- 3015173212
- 3007882731
- 3011610434
- 1423537
- 3012050423
- 1318694
- 3039454510
- 1000563940
- 3006425876
- 3008328690
- 3008998256
- 3003898360
- 1056553
- 2528981
- 3013288201
- 3014656749
- 3031282706
- 9612164
- 3011642792
- 3010966701
- 3016986313
- 2134244
- 2017865
- 3002807314
- 3030574705
- 1118880
- 9616099
- 1625425
- 3021951050
- 2024311
- 1000121056
- 8020616
- 9612126
- 3011237770
- 3002648230
- 3016591327
- 3007830707
- 1625685
- 3003289723
- 9617604
- 3017168767
- 3004785273
- 3006260740
- 3013162291
- 2032112
- 9616088
- 3008452825
- 2011171
- 3009144177
- 3004784537
- 3005232773
- 3013986346
- 1048735
- 3036802499
- 1319639
- 1018233
- 1835568
- 1054241
- 3008853977
- 1928237
- 2182208
- 3042279517
- 3003915875
- 1828424
- 1423507
- 1225687
- 3022815697
- 1018470
- 3017636737
- 1064858
- 3011623145
- 3031571797
- 3000268902
- 1721686
- 3017298588
- 2245270
- 9616666
- 9610847
Source Documents
Other 510(k) Records For Product Code DYB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 |
| K253741 | VStick Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025-10-23 |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 |