Cleared Traditional

K905663 - PEDIATRIC INTRA-AORTIC BALLOON CATHETERS

K905663 is the FDA 510(k) clearance for PEDIATRIC INTRA-AORTIC BALLOON CATHETERS by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 958-day FDA review.

K905663 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
958d
Days
Class 2
Risk

K905663 is an FDA 510(k) clearance for the PEDIATRIC INTRA-AORTIC BALLOON CATHETERS. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 958 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Datascope Corp. devices

Submission Details

510(k) Number K905663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date August 02, 1993
Days to Decision 958 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
833d slower than avg
Panel avg: 125d · This submission: 958d
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 K905663.
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000 · Datascope Corp. · Aug 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · Datascope Corp. · Aug 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · Datascope Corp. · Aug 1993
SYSTEM 97
K922235 · Datascope Corp. · Apr 1993
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · Datascope Corp. · Feb 1993