Atlas FDA

IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH

FDA 510(k) clearance K851295 · decided 1985-04-10

Clearance details

K-number
K851295
Device name
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
Applicant
Telectronics, Inc.
Decision
Substantially Equivalent
Date received
1985-04-01
Decision date
1985-04-10
Days to decision
9 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Suffield, CT, US
Third-party review
No
Expedited review
No

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RecordFirmDate
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
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MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210)Metronic, Inc.2003-05-16
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205)Biotronik, Inc.2003-04-24
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053)Oscor, Inc.2003-01-31
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803)Biotronik, Inc.2002-12-11
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099)Biotronik, Inc.2002-10-18
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669)Oscor, Inc.2002-03-28

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