The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Retrieval Balloons.
| Device ID | K821818 |
| 510k Number | K821818 |
| Device Name: | RETRIEVAL BALLOONS |
| Classification | Catheter, Urological |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-21 |
| Decision Date | 1982-09-24 |