Cleared Traditional

K972570 - HEARTPORT INTRODUCER SHEATH

K972570 is an FDA 510(k) clearance for HEARTPORT INTRODUCER SHEATH, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972570 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
83d
Days
Class 2
Risk

K972570 is an FDA 510(k) clearance for the HEARTPORT INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 83 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 Heartport, Inc. devices

FDA 510(k) Submission Details - K972570

510(k) Number K972570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date October 01, 1997
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 434
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K972570.
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · Arrow Intl., Inc. · Feb 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K974448 · Cordis Corp. · Feb 1998
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · Datascope Corp. · Nov 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · Daig Corp. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997