Cleared Traditional

K212026 - Amplatzer Steerable Delivery Sheath

K212026 is an FDA 510(k) clearance for Amplatzer Steerable Delivery Sheath, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K212026 · Abbott Medical · Cardiovascular device
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Sep 2021
Decision
90d
Days
Class 2
Risk

K212026 is an FDA 510(k) clearance for the Amplatzer Steerable Delivery Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Abbott Medical (Plymouth, US). The FDA issued a Cleared decision on September 27, 2021 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K212026

510(k) Number K212026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2021
Decision Date September 27, 2021
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K212026.
QuikPass Catheter
K214106 · Traverse Vascular, Inc. · Jan 2022
Guiding Catheter
K210009 · CenterPoint Systems, LLC · Nov 2021
XO Cross Support Catheter
K210322 · Transit Scientific, LLC · Oct 2021
Amplatzer Talisman Delivery Sheath
K212738 · Abbott Medical · Sep 2021
ViperCross Support Catheters
K212725 · Cardiovascular Systems, Inc. · Sep 2021
ViperCross Support Catheters
K211240 · Cardiovascular Systems, Inc. · Aug 2021