Submission Details
| 510(k) Number | K150201 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2015 |
| Decision Date | February 27, 2015 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
Cleared
Special
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
Feb 2015
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K150201 is an FDA 510(k) clearance for the Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on February 27, 2015, 29 days after receiving the submission on January 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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