Cleared Traditional

K884104 - USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR

K884104 is an FDA 510(k) clearance for USCI HEMAQUET(TM) INTRODUCER W/OBTURATOR, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K884104 · C.R. Bard, Inc. · Cardiovascular device
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Dec 1988
Decision
83d
Days
Class 2
Risk

K884104 is an FDA 510(k) clearance for the USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on December 21, 1988 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K884104

510(k) Number K884104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date December 21, 1988
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K884104.
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · Argon Medical Corp. · May 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · Oscor Medical Corp. · Mar 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · Daig Corp. · Feb 1989
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988
ACS FUNNEL INTRODUCER
K875158 · Advanced Cardiovascular Systems, Inc. · May 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp. · Feb 1988