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)
FDA 510(k) K223472 · Spectranetics, Inc.
510(k) numberK223472
Submission
- Device name
- 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)
- Applicant
- Spectranetics, Inc.
Colorado Springs, CO, US - Received
- November 17, 2022
- Decision date
- December 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | Cook Incorporated | 04/06/2021SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | 03/13/2025SE |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 12/08/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | 08/24/2022SE |
| K203540 | Bridge Occlusion BalloonMJN · Special | 12/23/2020SE |
| K180694 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Special | 04/05/2018SE |
| K172687 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…MCW · Traditional | 11/27/2017SE |
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy CathetersMCW · Traditional | 04/07/2017SE |
| K162561 | Turbo-Power (2.0mm) Laser Atherectomy CathetersMCW · Traditional | 01/05/2017SE |
| K161333 | TightRail Sub-C Rotating Dilator SheathDRE · Traditional | 07/08/2016SE |
| K153530 | Bridge Occlusion BalloonMJN · Traditional | 02/05/2016SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K223472) received a 510(k) decision of Substantially Equivalent on December 15, 2022, 28 days after the submission was received.
What is the product code of K223472?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.