510(k) K250468
- Device
- iSLEEVE Introducer Set
- Applicant
- Boston Scientific
- 510(k) number
- K250468
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-20
- Date received
- 2025-02-18
- 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
- N
Related Records
Applicant Contact
- Contact
- Elizabeth LaDriere
- Address
- One Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers
- 3017168767
- 3010665433
- 1450662
- 3021951050
- 3004134316
- 3031983053
- 3043337628
- 3007697249
- 2521402
- 3014687026
- 2248146
- 1423507
- 3022815697
- 3007603855
- 9617592
- 1061124
- 3009350690
- 3025028711
- 3011657089
- 3008307705
- 3017406698
- 3006131984
- 2183870
- 3011564431
- 9617465
- 3038188187
- 3037047821
- 3015453963
- 3008002401
- 3010291427
- 2183744
- 3012536737
- 3006260740
- 1644312
- 2134265
- 3009437315
- 1018470
- 1225698
- 3002648230
- 3011024991
- 3017060084
- 3022518300
- 3010055973
- 1318694
- 3031571797
- 3016591327
- 3030447506
- 3001124136
- 3013557562
- 9616099
- 2024168
- 2246552
- 3010131137
- 3007284313
- 3010141307
- 3001374820
- 1225687
- 1423537
- 1721676
- 1221019
- 1820334
- 2939561
- 2017865
- 3036802499
- 3006425876
- 3006950086
- 3012307300
- 3033589330
- 1220648
- 3013162291
- 3025341484
- 1824619
- 1064858
- 3003915875
- 3017636737
- 3002807314
- 9611612
- 1018233
- 3008403546
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 |