Cleared Traditional

K981660 - Bard 8 Fr.

K981660 is the FDA 510(k) clearance for Bard 8 Fr. by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K981660 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1998
Decision
158d
Days
Class 2
Risk

K981660 is an FDA 510(k) clearance for the Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 158 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K981660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date October 16, 1998
Days to Decision 158 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
33d slower than avg
Panel avg: 125d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K981660.
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · Arrow Intl., Inc. · May 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
K994157 · Datascope Corp. · Mar 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · Arrow Intl., Inc. · Feb 2000
IAB-04840-U
K970689 · Arrow Intl., Inc. · Jun 1998
BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
K980850 · C.R. Bard, Inc. · Jun 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
K980780 · Datascope Corp. · May 1998