The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Balloon Wedge Pressure Catheter.
| Device ID | K822034 |
| 510k Number | K822034 |
| Device Name: | BALLOON WEDGE PRESSURE CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis, MD 21401 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-12 |
| Decision Date | 1982-08-24 |