Cleared Traditional

EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA (K980631) - FDA 510(k) Clearance

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

K980631 · Embol-X, Inc. · Cardiovascular device
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Feb 1999
Decision
349d
Days
Class 2
Risk

K980631 is an FDA 510(k) clearance for the EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Embol-X, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Embol-X, Inc. devices

Submission Details

510(k) Number K980631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date February 02, 1999
Days to Decision 349 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
224d slower than avg
Panel avg: 125d · This submission: 349d
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.

Regulatory Peers - DXC Clamp, Vascular

All 203
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