Cleared Traditional

K852197 - LAP-CATH

K852197 is the FDA 510(k) clearance for LAP-CATH by Research Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K852197 · Research Medical, Inc. · Cardiovascular device
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Nov 1985
Decision
170d
Days
Class 2
Risk

K852197 is an FDA 510(k) clearance for the LAP-CATH. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 6, 1985 after a review of 170 days - an extended review cycle.

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 Research Medical, Inc. devices

Submission Details

510(k) Number K852197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date November 06, 1985
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 224
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K852197.
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · Advanced Cardiovascular Systems, Inc. · Mar 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · Mallinckrodt Critical Care · Jan 1986
LARIAT CATHETER
K844598 · Mallinckrodt Critical Care · Feb 1985
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984