Submission Details
| 510(k) Number | K070150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2007 |
| Decision Date | February 15, 2007 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
VASCUPUNCTURE PICC GUIDEWIRE
Feb 2007
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K070150 is an FDA 510(k) clearance for the 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 February 15, 2007, 30 days after receiving the submission on January 16, 2007. 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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