The following data is part of a premarket notification filed by Nexgen Medical Systems, Inc. with the FDA for Nexgen Peripheral Mechanical Retrieval Device - 200cm, Model Mrd-1000; 80 Cm, Model Mrd-2000.
| Device ID | K090932 |
| 510k Number | K090932 |
| Device Name: | NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 |
| Classification | Catheter, Embolectomy |
| Applicant | NEXGEN MEDICAL SYSTEMS, INC. 10471 DOUBLE R BLVD. SUITE C Reno, NV 89521 |
| Contact | John Kucharczyk |
| Correspondent | John Kucharczyk NEXGEN MEDICAL SYSTEMS, INC. 10471 DOUBLE R BLVD. SUITE C Reno, NV 89521 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-02 |
| Decision Date | 2009-09-24 |