Cleared Special

Amplatzer Talisman Delivery Sheath (K212738) - FDA 510(k) Clearance

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

K212738 · Abbott Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2021
Decision
28d
Days
Class 2
Risk

K212738 is an FDA 510(k) clearance for the Amplatzer Talisman Delivery Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on September 27, 2021 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Abbott Medical devices

Submission Details

510(k) Number K212738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2021
Decision Date September 27, 2021
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 316
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K212738.
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