The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Corvocet Coaxial Introducer.
| Device ID | K151373 |
| 510k Number | K151373 |
| Device Name: | Corvocet Coaxial Introducer |
| Classification | Biopsy Needle |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Ileana Garcia |
| Correspondent | Ileana Garcia Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2015-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450373757 | K151373 | 000 |
| 10884450333386 | K151373 | 000 |
| 20884450333376 | K151373 | 000 |
| 10884450333362 | K151373 | 000 |
| 10884450333355 | K151373 | 000 |
| 10884450333324 | K151373 | 000 |
| 10884450333348 | K151373 | 000 |
| 10884450333331 | K151373 | 000 |
| 10884450476175 | K151373 | 000 |
| 20884450476158 | K151373 | 000 |
| 10884450476243 | K151373 | 000 |
| 20884450476233 | K151373 | 000 |
| 10884450476205 | K151373 | 000 |
| 20884450333390 | K151373 | 000 |
| 10884450333409 | K151373 | 000 |
| 10884450373740 | K151373 | 000 |
| 20884450373730 | K151373 | 000 |
| 20884450373723 | K151373 | 000 |
| 20884450373716 | K151373 | 000 |
| 10884450373702 | K151373 | 000 |
| 10884450373696 | K151373 | 000 |
| 20884450373686 | K151373 | 000 |
| 10884450373672 | K151373 | 000 |
| 20884450373662 | K151373 | 000 |
| 10884450373658 | K151373 | 000 |
| 20884450333420 | K151373 | 000 |
| 10884450333416 | K151373 | 000 |
| 10884450476212 | K151373 | 000 |