The following data is part of a premarket notification filed by Catco Medical, Inc. with the FDA for Catco Silicone Dual Lumen Umbilical Vessel Catheter.
| Device ID | K944410 |
| 510k Number | K944410 |
| Device Name: | CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1995-04-05 |