Cleared Traditional

K885348 - A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL

K885348 is an FDA 510(k) clearance for A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL, manufactured by Mallinckroot, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K885348 · Mallinckroot, Inc. · Cardiovascular device
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May 1989
Decision
138d
Days
Class 2
Risk

K885348 is an FDA 510(k) clearance for the A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mallinckroot, Inc. (St Louis, US). The FDA issued a Cleared decision on May 15, 1989 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckroot, Inc. devices

FDA 510(k) Submission Details - K885348

510(k) Number K885348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date May 15, 1989
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 404
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K885348.
ARROW HANDS-OFF THERMO-PACE
K895268 · Arrow Intl., Inc. · Nov 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · Boston Scientific Corp · Aug 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206 · E-Z-Em, Inc. · May 1989
USCI 7F GUIDE CATHETER
K890420 · C.R. Bard, Inc. · Apr 1989
IMAGER FLUSH CATHETERS
K884354 · Medi-Tech, Inc. · Apr 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · C.R. Bard, Inc. · Jan 1989