Submission Details
| 510(k) Number | K143252 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2014 |
| Decision Date | April 23, 2015 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
Apr 2015
Decision
161d
Days
Class 2
Risk
About This 510(k) Submission
K143252 is an FDA 510(k) clearance for the Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Needle Tech Products, Inc. (North Attleboro, US). The FDA issued a Cleared decision on April 23, 2015, 161 days after receiving the submission on November 13, 2014. 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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