Product code DRE
- Device name
- Dilator, Vessel, For Percutaneous Catheterization
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1310
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 |
| K183036 | Dilator Sets | Cook Incorporated | 2018-12-20 |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018-10-29 |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017-10-16 |
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017-06-01 |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017-04-28 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017-01-06 |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | 2016-08-11 |
| K150932 | Sheath Introducer | Bioteque Corp. | 2016-07-22 |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016-07-08 |
| K151877 | MicroTract Access System | Arstasis, Inc. | 2015-08-07 |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | 2015-05-22 |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | 2015-03-04 |
| K141070 | SUPER SHEATH | Togo Medikit Co., Ltd. | 2015-01-15 |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Cook Vascular, Inc. | 2014-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729295839 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729295853 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729375555 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729742913 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729295822 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| H965457580 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457690 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457590 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457600 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457610 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457620 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457630 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457640 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457650 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457660 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457670 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457680 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457570 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457560 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457550 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457540 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457530 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457520 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457510 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457500 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457490 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H965457480 | AngioDynamics | NAVILYST MEDICAL, INC. | 2016-09-20 |
| H787181002040 | AngioDynamics | ANGIODYNAMICS, INC. | 2016-09-20 |
| H787181002030 | AngioDynamics | ANGIODYNAMICS, INC. | 2016-09-20 |
| H787181002010 | AngioDynamics | ANGIODYNAMICS, INC. | 2016-09-20 |