Cleared Traditional

K921247 - ZEPHYR INFUSION CATHETER

K921247 is the FDA 510(k) clearance for ZEPHYR INFUSION CATHETER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K921247 · Target Therapeutics · Cardiovascular device
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Jun 1993
Decision
470d
Days
Class 2
Risk

K921247 is an FDA 510(k) clearance for the ZEPHYR INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 470 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 Target Therapeutics devices

Submission Details

510(k) Number K921247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date June 29, 1993
Days to Decision 470 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
345d slower than avg
Panel avg: 125d · This submission: 470d
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 K921247.
SCIMED(R) VENTURE(TM) INFUSION CATHETER
K931335 · Scimed Life Systems, Inc. · Jul 1994
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · Scimed Life Systems, Inc. · Dec 1993
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
SELECTIVE INFUSION II CATHETER
K914751 · Advanced Cardiovascular Systems, Inc. · May 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
MAGIC INFUSION CATHETER
K923368 · Target Therapeutics · Apr 1993