MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

Catheter, Angioplasty, Peripheral, Transluminal

INTENSIVE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Modified Ivt Peripheral Atherectomy System.

Pre-market Notification Details

Device IDK896403
510k NumberK896403
Device Name:MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego,  CA  92123
ContactKevin E Daly
CorrespondentKevin E Daly
INTENSIVE TECHNOLOGY, INC. 3574 RUFFIN RD. San Diego,  CA  92123
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-07
Decision Date1990-03-06

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