Cleared Traditional

K931335 - SCIMED VENTURE(TM) INFUSION CATHETER

K931335 is the FDA 510(k) clearance for SCIMED VENTURE(TM) INFUSION CATHETER by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 498-day FDA review.

K931335 · Scimed Life Systems, Inc. · Cardiovascular device
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Jul 1994
Decision
498d
Days
Class 2
Risk

K931335 is an FDA 510(k) clearance for the SCIMED(R) VENTURE(TM) INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K931335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date July 27, 1994
Days to Decision 498 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
373d slower than avg
Panel avg: 125d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K931335.
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · Scimed Life Systems, Inc. · Jul 1995
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · Scimed Life Systems, Inc. · Jan 1995
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · Scimed Life Systems, Inc. · Dec 1993
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
ZEPHYR INFUSION CATHETER
K921247 · Target Therapeutics · Jun 1993