Cleared Traditional

K222873 - Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K222873 · Medtronic · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2022
Decision
46d
Days
Class 2
Risk

K222873 is an FDA 510(k) clearance for the Attain Command + SureValve Delivery System, Attain Select II + SureValve deli.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on November 7, 2022 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic devices

Submission Details

510(k) Number K222873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2022
Decision Date November 07, 2022
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04863664 Completed Interventional Industry-sponsored

Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)

998
Patients (actual)
55
Sites
Treatment
Purpose
Open label
Masking
Condition studied Tachyarrhythmia
Study design Single group
Eligibility All sexes · 12 Years+
Principal investigator George Crossley, MD
Sponsor Medtronic Cardiac Rhythm and Heart Failure (industry)
Started 2021-06-21 → Primary completion 2025-09-03 → Completed 2025-11-06
Primary outcome
LEADR: Estimate the rate of major Lead complication-free rate at 6 months
Secondary outcome
LEADR: Estimate the fracture-free rate of the Next Generation ICD lead
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQY Catheter, Percutaneous

All 887
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K222873.
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