The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Flow Directed Thermodilution Balloon Catheter.
| Device ID | K935404 |
| 510k Number | K935404 |
| Device Name: | FLOW DIRECTED THERMODILUTION BALLOON CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LN., SUITE 6 West Berlin, NJ 08091 |
| Contact | James L Skaggs, Sr. |
| Correspondent | James L Skaggs, Sr. 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 | 1993-11-09 |
| Decision Date | 1994-05-03 |