The following data is part of a premarket notification filed by Nexgen Medical Systems, Inc. with the FDA for Nexgen Expandable Catheter.
| Device ID | K102925 |
| 510k Number | K102925 |
| Device Name: | NEXGEN EXPANDABLE CATHETER |
| Classification | Introducer, Catheter |
| Applicant | NEXGEN MEDICAL SYSTEMS, INC. 1050 W. NASA BLVD. SUITE 136 Melbourne, FL 32901 |
| Contact | Craig Pagan |
| Correspondent | Craig Pagan NEXGEN MEDICAL SYSTEMS, INC. 1050 W. NASA BLVD. SUITE 136 Melbourne, FL 32901 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2011-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855975007055 | K102925 | 000 |
| 00855975007048 | K102925 | 000 |