Cleared Traditional

PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) (K864167) - FDA 510(k) Clearance

K864167 · Datascope Corp. · Cardiovascular device
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Nov 1986
Decision
13d
Days
-
Risk

K864167 is an FDA 510(k) clearance for the PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED).

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on November 6, 1986 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Datascope Corp. devices

Submission Details

510(k) Number K864167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date November 06, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -