Cleared Traditional

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

K864167 · Datascope Corp. · Cardiovascular device
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, 13 days after receiving the submission on October 24, 1986.

This device falls under the Cardiovascular FDA review panel.

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 -

Device Classification

Product Code -
Device Class -