Cleared Traditional

K962177 - BARD TAPERSEAL INTRA-AORTIC BALLOON CAT...

K962177 is the FDA 510(k) clearance for BARD TAPERSEAL INTRA-AORTIC BALLOON CAT... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K962177 · C.R. Bard, Inc. · Cardiovascular device
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Sep 1996
Decision
90d
Days
Class 2
Risk

K962177 is an FDA 510(k) clearance for the BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT. 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 September 4, 1996 after a review of 90 days - within the typical 510(k) review window.

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 K962177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date September 04, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K962177.
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104 · Arrow Intl., Inc. · Feb 1997
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · Datascope Corp. · Nov 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
K963187 · Boston Scientific Corp · Nov 1996
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
K961358 · Arrow Intl., Inc. · Jul 1996
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
K960713 · Arrow Intl., Inc. · May 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · Datascope Corp. · Apr 1996