Cleared Traditional

K994157 - DATASCOPE'S 8FR. POLYMIDE 25CC

K994157 is the FDA 510(k) clearance for DATASCOPE'S 8FR. POLYMIDE 25CC by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K994157 · Datascope Corp. · Cardiovascular device
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Mar 2000
Decision
95d
Days
Class 2
Risk

K994157 is an FDA 510(k) clearance for the DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684.... Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on March 13, 2000 after a review of 95 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 Datascope Corp. devices

Submission Details

510(k) Number K994157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1999
Decision Date March 13, 2000
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
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 K994157.
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
K003598 · Datascope Corp. · Dec 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · Datascope Corp. · Oct 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
K000729 · Arrow Intl., Inc. · May 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · Arrow Intl., Inc. · Feb 2000
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660 · C.R. Bard, Inc. · Oct 1998
IAB-04840-U
K970689 · Arrow Intl., Inc. · Jun 1998