The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Cath-finder System.
Device ID | K884701 |
510k Number | K884701 |
Device Name: | CATH-FINDER SYSTEM |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward 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 | 1988-11-09 |
Decision Date | 1989-02-01 |