The following data is part of a premarket notification filed by Jomed Catheter, Inc. with the FDA for Joguide Cardiovascular Guiding C Atheter.
| Device ID | K021088 |
| 510k Number | K021088 |
| Device Name: | JOGUIDE CARDIOVASCULAR GUIDING C ATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | JOMED CATHETER, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Norman L Hall |
| Correspondent | Norman L Hall JOMED CATHETER, INC. 604 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2002-05-02 |