Atlas FDA

IMPLANTABLE PROGRAM. CARDIAC PULSE GEN

FDA 510(k) clearance K831771 · decided 1983-08-16

Clearance details

K-number
K831771
Device name
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
Applicant
Telectronics, Inc.
Decision
Substantially Equivalent
Date received
1983-06-02
Decision date
1983-08-16
Days to decision
75 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
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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
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CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
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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