Cleared Special

Breezeway II (K210627) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210627 · Oscor, Inc. · Cardiovascular device
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Jun 2021
Decision
93d
Days
Class 2
Risk

K210627 is an FDA 510(k) clearance for the Breezeway II. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 3, 2021 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oscor, Inc. devices

Submission Details

510(k) Number K210627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2021
Decision Date June 03, 2021
Days to Decision 93 days
Submission Type Special
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
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

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 281
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