The following data is part of a premarket notification filed by Jomed, Inc. with the FDA for Jowire Neo's Ptca Catheter Guidewires, Models Ag141000, Ag142000, Ag143000, Ag141002, Ag141010, Ag14m060 & Ag14m050.
| Device ID | K022762 |
| 510k Number | K022762 |
| Device Name: | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 |
| Classification | Wire, Guide, Catheter |
| Applicant | JOMED, INC. 15330 AVE. OF SCIENCE, SUITE 200 San Diego, CA 92128 |
| Contact | Terry Schultz |
| Correspondent | Terry Schultz JOMED, INC. 15330 AVE. OF SCIENCE, SUITE 200 San Diego, CA 92128 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-20 |
| Decision Date | 2002-12-16 |
| Summary: | summary |