Cleared Traditional

NHANCER (K121077) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121077 · Imds Operations B.V. · Cardiovascular device
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Dec 2012
Decision
256d
Days
Class 2
Risk

K121077 is an FDA 510(k) clearance for the NHANCER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Imds Operations B.V. (Roden, Drenthe, NL). The FDA issued a Cleared decision on December 21, 2012 after a review of 256 days - an extended review 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: 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 Imds Operations B.V. devices

Submission Details

510(k) Number K121077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2012
Decision Date December 21, 2012
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 319
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K121077.
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K122940 · Cook, Inc. · Mar 2013
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
K121219 · Medtronic, Inc. · Sep 2012
RUBICON 18 SUPPORT CATHETER
K122394 · Boston Scientific Corp · Aug 2012
CONCIERGE GUIDING CATHETER
K121051 · Merit Medical Systems, Inc. · Jun 2012