The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Quick-cross Extreme Support Catheter, Quick-cross Select Support Catheter.
| Device ID | K150201 |
| 510k Number | K150201 |
| Device Name: | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Christine Godleski |
| Correspondent | Pharoah Garma SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813132029597 | K150201 | 000 |
| 20813132029429 | K150201 | 000 |
| 20813132029436 | K150201 | 000 |
| 20813132029443 | K150201 | 000 |
| 20813132029450 | K150201 | 000 |
| 00813132029463 | K150201 | 000 |
| 20813132029474 | K150201 | 000 |
| 20813132029481 | K150201 | 000 |
| 20813132029498 | K150201 | 000 |
| 20813132029511 | K150201 | 000 |
| 20813132029528 | K150201 | 000 |
| 20813132029535 | K150201 | 000 |
| 20813132029542 | K150201 | 000 |
| 20813132029559 | K150201 | 000 |
| 20813132029566 | K150201 | 000 |
| 20813132029573 | K150201 | 000 |
| 20813132029580 | K150201 | 000 |
| 20813132029412 | K150201 | 000 |