Submission Details
| 510(k) Number | K033542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 10, 2003 |
| Decision Date | December 05, 2003 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
Dec 2003
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K033542 is an FDA 510(k) clearance for the EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 5, 2003, 25 days after receiving the submission on November 10, 2003. 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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