Cleared Traditional

K973007 - DATASCOPE'S 10 FR. FLEXISHEATH PERCUTAN...

K973007 is the FDA 510(k) clearance for DATASCOPE'S 10 FR. FLEXISHEATH PERCUTAN... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973007 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
85d
Days
Class 2
Risk

K973007 is an FDA 510(k) clearance for the DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datascope Corp. devices

Submission Details

510(k) Number K973007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date November 06, 1997
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 378
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K973007.
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TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997