Cleared Traditional

K863608 - DATASCOPE BALLOON DILATATION CATHETER (FDA 510(k) Clearance)

K863608 · Datascope Corp. · Cardiovascular device
Feb 1987
Decision
147d
Days
-
Risk

K863608 is an FDA 510(k) clearance for the DATASCOPE BALLOON DILATATION CATHETER..

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on February 10, 1987, 147 days after receiving the submission on September 16, 1986.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K863608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date February 10, 1987
Days to Decision 147 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -

Device Classification

Product Code -
Device Class -