Cleared Traditional

K852197 - LAP-CATH

K852197 is an FDA 510(k) clearance for LAP-CATH, manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K852197

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
Combination Product No
PCCP Authorized No
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.

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 365
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
FAP-CATH
K852456 · Research Medical, Inc. · Nov 1985
OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
K844854 · Vas-Cath of Canada , Ltd. · May 1985
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
K844800 · Vas-Cath of Canada , Ltd. · May 1985