The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cath-finder(tm) Catheter Tracking System.
Device ID | K904150 |
510k Number | K904150 |
Device Name: | CATH-FINDER(TM) CATHETER TRACKING SYSTEM |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | W Numainville |
Correspondent | W Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-07 |
Decision Date | 1990-11-19 |