The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Flow Direct Thermodilut Balloon Cath Heparin Coated.
| Device ID | K940547 |
| 510k Number | K940547 |
| Device Name: | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED |
| Classification | Catheter, Flow Directed |
| Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
| Contact | James L Skaggs |
| Correspondent | James L Skaggs J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-08-11 |