The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Olbert Catheter System With Sidewinder Curve.
| Device ID | K862550 |
| 510k Number | K862550 |
| Device Name: | OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Jane Aoyagi |
| Correspondent | Jane Aoyagi MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-09-02 |