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 |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026-07-27 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450499221 | Merit MAK™ | Merit Medical Systems, Inc. | 2026-10-30 |
| 00884450499245 | Merit MAK™ | Merit Medical Systems, Inc. | 2026-10-30 |
| 00884450499870 | Merit S-MAK™ | Merit Medical Systems, Inc. | 2026-10-30 |
| 00884450839362 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2026-10-30 |
| 00884450499191 | Merit MAK™ | Merit Medical Systems, Inc. | 2026-10-30 |
| 00884450838129 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2026-10-29 |
| 10884450708443 | Prelude® | Merit Medical Systems, Inc. | 2026-10-29 |
| 00884450531952 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-11-12 |
| 00884450532171 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-10-28 |
| 00884450531914 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-10-19 |
| 00884450531921 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-09-13 |
| 00884450532065 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-08-30 |
| 00884450532157 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-08-12 |
| 00884450532164 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-08-11 |
| 00884450532133 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-08-10 |
| 00884450531945 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-27 |
| 00884450531730 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-27 |
| 00884450531716 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-26 |
| 00884450532140 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-22 |
| 00884450532300 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-22 |
| 00884450531709 | Prelude Roadster™ | Merit Medical Systems, Inc. | 2022-07-21 |
| 00884450525197 | COBRA-OS | Merit Medical Systems, Inc. | 2022-05-19 |
| 00803622146947 | Vascular Dilator Kit | LIVANOVA USA, INC. | 2020-08-19 |
| 00841268106970 | Micro-Introducer Set | GALT MEDICAL CORP. | 2017-08-09 |
| 00841268106963 | Micro-Introducer Set | GALT MEDICAL CORP. | 2017-08-09 |
| 00827002535756 | Micropuncture | COOK INCORPORATED | 2016-09-24 |
| 00827002535749 | Micropuncture | COOK INCORPORATED | 2016-09-24 |
| 00827002033405 | Micropuncture | COOK INCORPORATED | 2016-09-24 |
| 00690103192391 | EDWARDS DILATOR KIT | Edwards Lifesciences LLC | 2015-12-01 |
| 00803622112522 | Vascular Dilator Kit | LIVANOVA USA, INC. | 2014-12-22 |