The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Heart Cath Tray, Sterile, Disposable.
| Device ID | K981441 |
| 510k Number | K981441 |
| Device Name: | HEART CATH TRAY, STERILE, DISPOSABLE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-21 |
| Decision Date | 1998-07-10 |