The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Intravascular Catheter.
Device ID | K803238 |
510k Number | K803238 |
Device Name: | INTRAVASCULAR CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-23 |
Decision Date | 1981-04-23 |