Cleared Traditional

K903848 - DIAGNOSTIC INTRASCULAR CATHETER

K903848 is the FDA 510(k) clearance for DIAGNOSTIC INTRASCULAR CATHETER by Applied Vascular Devices, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K903848 · Applied Vascular Devices, Inc. · Cardiovascular device
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Mar 1991
Decision
216d
Days
Class 2
Risk

K903848 is an FDA 510(k) clearance for the DIAGNOSTIC INTRASCULAR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 25, 1991 after a review of 216 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 Applied Vascular Devices, Inc. devices

Submission Details

510(k) Number K903848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date March 25, 1991
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 125d · This submission: 216d
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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K903848.
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · Baxter Healthcare Corp · Jun 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · Baxter Healthcare Corp · Apr 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991
ACS ANGIOSCOPIC CATHETER
K905715 · Advanced Cardiovascular Systems, Inc. · Mar 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · Scimed Life Systems, Inc. · Feb 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991