510(k) K253616
- Device
- ProtekDilate Vascular Access Kit
- Applicant
- Sorin Group Italia S.R.L.
- 510(k) number
- K253616
- Product code
- DRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-19
- Date received
- 2025-11-18
- Regulation
- 870.1310
- Classification name
- Dilator, Vessel, For Percutaneous Catheterization
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Luigi Vecchi
- Address
- Via Statale 12 Nord, 86 Mirandola ( Modena) IT 41037 41037
FDA Registration Numbers#
- 2527072
- 1123137
- 3009211636
- 3032916632
- 3030447506
- 3012453745
- 1018233
- 3031571797
- 3007882731
- 3005580113
- 1625425
- 2011171
- 3000126629
- 2182269
- 3012536737
- 3004111573
- 1000121056
- 2030624
- 1724474
- 3025341484
- 3033589330
- 2015691
- 1054241
- 2124215
- 2183744
- 9611665
- 3007146453
- 3005334138
- 2032521
- 1718850
- 9610139
- 8010762
- 9616662
- 3013666336
- 3011623145
- 1928237
- 3015309643
- 1319639
- 1649395
- 3004784537
- 1043214
- 3007284006
- 1319211
- 1820334
- 3003915875
- 3007695959
- 3011468686
- 3010665433
- 3036802499
- 3009888344
- 2182208
- 3011642792
- 3027260597
- 9680841
- 3003637635
- 1055236
- 3011657089
- 1828424
- 3002807314
- 1644312
- 9610849
- 3018565086
- 1282497
- 3030714660
- 1722746
- 2029275
- 3006283319
- 2246552
- 3006082230
- 9616683
- 9616099
- 3020778
- 1721504
- 3008500478
- 2032228
- 3019807891
- 3006950086
- 1721686
- 1000523114
- 1721676
Source Documents#
Other 510(k) Records For Product Code DRE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251325 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2025-05-29 |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025-01-15 |
| K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2024-07-12 |
| K233647 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Company, Inc. | 2023-12-14 |
| K232609 | Micro Ace™ Advanced Micro Access System | Merit Medical Systems, Inc. | 2023-09-27 |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | Spectranetics, Inc. | 2022-12-15 |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022-08-24 |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | 2022-02-17 |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021-04-06 |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020-06-12 |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | 2020-05-06 |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020-03-19 |
| K192195 | Sterile Dilator | Galt Medical Corp. | 2019-09-26 |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019-04-10 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 |