Submission Details
| 510(k) Number | K982559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 23, 1998 |
| Decision Date | February 01, 1999 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
GUIDEWIRE
Feb 1999
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K982559 is an FDA 510(k) clearance for the 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 February 1, 1999, 193 days after receiving the submission on July 23, 1998. 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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