510(k) K092378
- Device
- SPECTRANETICS VISISHEATH DILATOR SHEATH
- Applicant
- SPECTRANETICS CORP.
- 510(k) number
- K092378
- Product code
- DRE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-11-02
- Date received
- 2009-08-05
- Regulation
- 870.1310
- Classification name
- Dilator, Vessel, For Percutaneous Catheterization
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHERYL HASTINGS
- Address
- 96 Talamine Ct. Colorado Springs CO US 80907 80907
FDA Registration Numbers#
- 1722746
- 3007882731
- 3007146453
- 2029275
- 3007284006
- 3011468686
- 2528981
- 3014656749
- 3011642792
- 3002807314
- 3030574705
- 3027260597
- 9616099
- 1625425
- 1000121056
- 9612126
- 2032521
- 2011171
- 3004784537
- 9610139
- 3036802499
- 1319639
- 1018233
- 1054241
- 1928237
- 2182208
- 3003915875
- 1828424
- 3011623145
- 3031571797
- 1721686
- 9611665
- 3005580113
- 3003637635
- 2124215
- 1123137
- 1055236
- 2522007
- 1016427
- 3004111573
- 3012453745
- 1644312
- 2953359
- 3008500478
- 3025341484
- 3032916632
- 9610849
- 2032228
- 1643817
- 3038188187
- 1649395
- 1820334
- 3013666336
- 9680841
- 1000523114
- 2518902
- 8010762
- 2527072
- 3009888344
- 2015691
- 1043214
- 3010665433
- 2246552
- 3018565086
- 9616683
- 3030714660
- 3033589330
- 3009211636
- 3020778
- 3019807891
- 1000393132
- 3005941719
- 3015225571
- 3006082230
- 2648045
- 9681477
- 3000126629
- 3019751610
- 3005334138
- 1718850
Source Documents#
Other 510(k) Records For Product Code DRE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025-12-19 |
| 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 |
Legacy Summary#
summary
FDA Review#
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