Cleared Traditional

K062852 - BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER

K062852 is an FDA 510(k) clearance for BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, manufactured by Onset Medical Corporation. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K062852 · Onset Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
151d
Days
Class 2
Risk

K062852 is an FDA 510(k) clearance for the BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Onset Medical Corporation (Mission Viejo, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 151 days - an extended review 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: 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 Onset Medical Corporation devices

FDA 510(k) Submission Details - K062852

510(k) Number K062852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date February 23, 2007
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K062852.
INTRAVASCULAR INTRODUCER SYSTEM
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K070417 · St Jude Medical · Jun 2007
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MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · Terumo Medical Corp. · Oct 2006
MODIFICATION TO GLIDESHEATH
K062858 · Terumo Medical Corp. · Oct 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · St Jude Medical · Aug 2006