Cleared Traditional

K920907 - OVER THE NEEDLE SPLITABLE CATHETER W/FU...

K920907 is the FDA 510(k) clearance for OVER THE NEEDLE SPLITABLE CATHETER W/FU... by Teleflexmedical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K920907 · Teleflexmedical, Inc. · Cardiovascular device
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Oct 1992
Decision
222d
Days
Class 2
Risk

K920907 is an FDA 510(k) clearance for the OVER THE NEEDLE SPLITABLE CATHETER W/FUNNEL LOCATO. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on October 6, 1992 after a review of 222 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K920907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1992
Decision Date October 06, 1992
Days to Decision 222 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
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K920907.
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · Arrow Intl., Inc. · Apr 1993
INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
K923603 · Kontron Instruments, Inc. · Mar 1993
OVER THE NEEDLE SPLITABLE CATHETER ASSEMBLY TYPE 1
K920908 · Teleflexmedical, Inc. · Oct 1992
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · Daig Corp. · Jun 1992