Cleared Traditional

OPTIMA MPT AND SPT PACEMAKERS

K891231 · Telectronics, Inc. · Cardiovascular
Sep 1989
Decision
189d
Days
Class 3
Risk

About This 510(k) Submission

K891231 is an FDA 510(k) clearance for the OPTIMA MPT AND SPT PACEMAKERS, a Implantable Pacemaker Pulse-generator (Class III — Premarket Approval, product code DXY), submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on September 12, 1989, 189 days after receiving the submission on March 7, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3610.

Submission Details

510(k) Number K891231 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1989
Decision Date September 12, 1989
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXY — Implantable Pacemaker Pulse-generator
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3610

Similar Devices — DXY Implantable Pacemaker Pulse-generator

All 460
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · Biotronik, Inc. · Nov 1999
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · Ela Medical, Inc. · Aug 1997
PIKOS LP 01, PIKOS LP E01
K945627 · Biotronik, Inc. · Mar 1996
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · Medtronic Vascular · Dec 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092 · Medtronic Vascular · Dec 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · Biotronik, Inc. · Sep 1995