Cleared Traditional

K982278 - MICRINS MICRO ANASTOMOSIS CLAMP (FDA 510(k) Clearance)

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

K982278 · Micrins Surgical, Inc. · Cardiovascular device
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Mar 1999
Decision
270d
Days
Class 2
Risk

K982278 is an FDA 510(k) clearance for the MICRINS MICRO ANASTOMOSIS CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Micrins Surgical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 26, 1999 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Micrins Surgical, Inc. devices

Submission Details

510(k) Number K982278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1998
Decision Date March 26, 1999
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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.

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All 201
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