Submission Details
| 510(k) Number | K043398 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 2004 |
| Decision Date | March 01, 2005 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
Mar 2005
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K043398 is an FDA 510(k) clearance for the MODIFICATION TO VASCUPUNCTURE PICC 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 March 1, 2005, 81 days after receiving the submission on December 10, 2004. 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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