The following data is part of a premarket notification filed by Nexgen Medical Systems, Inc. with the FDA for Nexgen Peripheral Guide Catheter.
| Device ID | K102979 |
| 510k Number | K102979 |
| Device Name: | NEXGEN PERIPHERAL GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2011-01-18 |
| Summary: | summary |