The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Right Atrial Catheter Kits.
| Device ID | K920331 |
| 510k Number | K920331 |
| Device Name: | RIGHT ATRIAL CATHETER KITS |
| Classification | Catheter, Percutaneous |
| Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Contact | Balbir Kapany |
| Correspondent | Balbir Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-23 |
| Decision Date | 1992-04-22 |