The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Cath-seal, 13+14f & Transseptal Catheter Intro.
| Device ID | K861984 |
| 510k Number | K861984 |
| Device Name: | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-22 |
| Decision Date | 1986-08-05 |