Submission Details
| 510(k) Number | K212784 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 2021 |
| Decision Date | August 24, 2022 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
TightRail Guardian Motorized Dilator Sheath
Aug 2022
Decision
357d
Days
Class 2
Risk
About This 510(k) Submission
K212784 is an FDA 510(k) clearance for the TightRail Guardian Motorized Dilator Sheath, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on August 24, 2022, 357 days after receiving the submission on September 1, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.
Device Classification
| Product Code | DRE — Dilator, Vessel, For Percutaneous Catheterization |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1310 |
Manufacturer
Similar Devices — DRE Dilator, Vessel, For Percutaneous Catheterization
All 103
K253616 · Sorin Group Italia S.R.L.
· Dec 2025
K251325 · Baylis Medical Company, Inc.
· May 2025
K242229 · Merit Medical Systems, Inc.
· Jan 2025
K241720 · Baylis Medical Company, Inc.
· Jul 2024
K233647 · Baylis Medical Company, Inc.
· Dec 2023
K232609 · Merit Medical Systems, Inc.
· Sep 2023
More from Spectranetics, Inc.
View all
K223472
· DRE · Dec 2022
K222837
· MCW · Dec 2022
DEN210024
· QRJ · Dec 2021
K203540
· MJN · Dec 2020
K180694
· MCW · Apr 2018