BALLOON THERMODILUTION CATHETER #7164&

Catheter, Flow Directed

CRITIKON COMPANY,LLC

The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Balloon Thermodilution Catheter #7164&.

Pre-market Notification Details

Device IDK823433
510k NumberK823433
Device Name:BALLOON THERMODILUTION CATHETER #7164&
ClassificationCatheter, Flow Directed
Applicant CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker,  MI  49534
Correspondent
CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-16
Decision Date1982-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60801902008758 K823433 000
00801902004611 K823433 000
00801902008749 K823433 000
30801902003950 K823433 000
30801902003967 K823433 000
60801902004392 K823433 000
40801902004558 K823433 000
40801902004565 K823433 000
40801902004619 K823433 000
40801902008747 K823433 000
00801902004567 K823433 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.