Submission Details
| 510(k) Number | K230637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 2023 |
| Decision Date | May 05, 2023 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Wattson temporary pacing guidewire (2250)
May 2023
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K230637 is an FDA 510(k) clearance for the Wattson temporary pacing guidewire (2250), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on May 5, 2023, 59 days after receiving the submission on March 7, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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