The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Swan Ganz.
Device ID | K771043 |
510k Number | K771043 |
Device Name: | SWAN GANZ |
Classification | Catheter, Flow Directed |
Applicant | CLINCAL INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYG |
CFR Regulation Number | 870.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-09 |
Decision Date | 1977-12-20 |