Cleared Traditional

K895932 - PSG(TM) EDM(TM) INFUSION CATHETER

K895932 is an FDA 510(k) clearance for PSG(TM) EDM(TM) INFUSION CATHETER, manufactured by Peripheral Systems Group. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K895932 · Peripheral Systems Group · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
86d
Days
Class 2
Risk

K895932 is an FDA 510(k) clearance for the PSG(TM) EDM(TM) INFUSION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Peripheral Systems Group (Mountain View, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Peripheral Systems Group devices

FDA 510(k) Submission Details - K895932

510(k) Number K895932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date January 04, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K895932.
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · Sep 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989