Atlas FDA

IMPLANTABLE PROGRAMMABLE PULSE GENERATOR

FDA 510(k) clearance K854560 · decided 1986-01-16

Clearance details

K-number
K854560
Device name
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
Applicant
Telectronics, Inc.
Decision
Substantially Equivalent
Date received
1985-11-14
Decision date
1986-01-16
Days to decision
63 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Suffield, CT, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Telectronics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072)Ela Medical, Inc.1997-08-29
PIKOS LP 01, PIKOS LP E01 (K945627)Biotronik, Inc.1996-03-04
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866)Medtronic Vascular1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092)Medtronic Vascular1995-12-15
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328)Biotronik, Inc.1995-09-29
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
TELECTRONICS PASAR MODEL 4171 PG (P850027/S006)Telectronics, Inc.1990-05-09
TELECTRONICS PASAR MODEL 4171 PG (P850027/S003)Telectronics, Inc.1990-03-22
TELECTRONICS PASAR MODEL 4171 PG (P850027/S005)Telectronics, Inc.1990-02-02
TELECTRONICS PASAR MODEL 4171 PG (P850027/S002)Telectronics, Inc.1989-04-18
TELECTRONICS PASAR MODEL 4171 PG (P850027/S001)Telectronics, Inc.1987-03-27
TELECTRONICS PASAR MODEL 4171 PG (P850027)Telectronics, Inc.1986-09-30