Product code DTF— Cardiovascular

TORQUE HEX WRENCH

Classification name: Tools, Pacemaker Service
Device class: Class 1
Regulation: 21 CFR 870.3730
Advisory panel: Cardiovascular
Total cleared: 2
First cleared: 1978-07-27
Most recent: 1988-01-27

Market context for product code DTF

FDA has cleared 2 devices under product code DTF between 1978 and 1988, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19881 clearance
19781 clearance

Top applicants under product code DTF

Telectronics, Inc.1 clearance
Cardiac Pacemakers, Inc.1 clearance

Recent clearances under product code DTF

K875147 — TORQUE HEX WRENCHCardiac Pacemakers, Inc.·1988-01-27
K781179 — WRENCH, GEXAGON, DRIVERTelectronics, Inc.·1978-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.