The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Balloon Catheter Inflation Device.
| Device ID | K972964 |
| 510k Number | K972964 |
| Device Name: | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE |
| Classification | Dilator, Urethral |
| Applicant | ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. PO BOX 564 Arab, AL 35016 |
| Contact | Dan Clark |
| Correspondent | Dan Clark ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. PO BOX 564 Arab, AL 35016 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-10-10 |
| Summary: | summary |