Cleared Traditional

K121077 - NHANCER

K121077 is an FDA 510(k) clearance for NHANCER, manufactured by Imds Operations B.V.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 256-day FDA review.

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

FDA 510(k) Submission Details - K121077

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.

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 620
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