Cleared Special

K012489 - MODIFICATION TO: X-SEPT TRANSSEPTAL SHE...

K012489 is an FDA 510(k) clearance for MODIFICATION TO: X-SEPT TRANSSEPTAL SHE..., manufactured by Appriva Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 27-day FDA review.

K012489 · Appriva Medical, Inc. · Cardiovascular device
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Aug 2001
Decision
27d
Days
Class 2
Risk

K012489 is an FDA 510(k) clearance for the MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DIL.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Appriva Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 30, 2001 after a review of 27 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Appriva Medical, Inc. devices

FDA 510(k) Submission Details - K012489

510(k) Number K012489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2001
Decision Date August 30, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 440
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