Submission Details
| 510(k) Number | K220647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2022 |
| Decision Date | August 18, 2022 |
| Days to Decision | 164 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Aug 2022
Decision
164d
Days
Class 2
Risk
About This 510(k) Submission
K220647 is an FDA 510(k) clearance for the GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on August 18, 2022, 164 days after receiving the submission on March 7, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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