The following data is part of a premarket notification filed by J-lloyd Medical, Inc. with the FDA for Flow Directed Thermodilution/infusion Balloon Catheter (575-110p).
| Device ID | K963248 |
| 510k Number | K963248 |
| Device Name: | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) |
| Classification | Catheter, Flow Directed |
| Applicant | J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 West Berlin, NJ 08091 |
| Contact | James L Skaggs, Sr. |
| Correspondent | James L Skaggs, Sr. J-LLOYD MEDICAL, INC. 415 COMMERCE LANE, SUITE 7 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 | 1996-08-19 |
| Decision Date | 1997-02-03 |
| Summary: | summary |