The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Neuron Support Catheter System, Model 5f/6f.
| Device ID | K070970 |
| 510k Number | K070970 |
| Device Name: | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
| Classification | Catheter, Percutaneous |
| Applicant | PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548012131 | K070970 | 000 |
| 00815948024045 | K070970 | 000 |
| 00815948024052 | K070970 | 000 |
| 00815948024069 | K070970 | 000 |
| 00815948024076 | K070970 | 000 |
| 00815948024083 | K070970 | 000 |
| 00814548010137 | K070970 | 000 |
| 00814548010144 | K070970 | 000 |
| 00814548012063 | K070970 | 000 |
| 00814548012070 | K070970 | 000 |
| 00814548012087 | K070970 | 000 |
| 00814548012094 | K070970 | 000 |
| 00814548012100 | K070970 | 000 |
| 00814548012117 | K070970 | 000 |
| 00814548012124 | K070970 | 000 |
| 00815948024038 | K070970 | 000 |