Submission Details
| 510(k) Number | K033321 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 2003 |
| Decision Date | November 05, 2003 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
SELECTIVA SB GUIDEWIRE
Nov 2003
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K033321 is an FDA 510(k) clearance for the SELECTIVA SB GUIDEWIRE, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 5, 2003, 21 days after receiving the submission on October 15, 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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