Cleared Traditional

K962177 - BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT

K962177 is an FDA 510(k) clearance for BARD TAPERSEAL INTRA-AORTIC BALLOON CAT..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K962177

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.

DSP Device Classification - Class 2, Special Controls

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 145
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