Atlas FDA

MODEL 4815 ADAPTER

FDA 510(k) clearance K002496 · decided 2000-10-10

Clearance details

K-number
K002496
Device name
MODEL 4815 ADAPTER
Applicant
Pace Medical
Decision
Substantially Equivalent
Date received
2000-08-14
Decision date
2000-10-10
Days to decision
57 days
Clearance type
Traditional
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Waltham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER (P920032/S008)Pace Medical2002-02-20
BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170 (P920032/S007)Pace Medical2001-10-26
MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER (P920032/S006)Pace Medical2001-04-06
MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005)Pace Medical2000-02-02
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S004)Pace Medical1998-02-27
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003)Pace Medical1996-07-19
MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER (P920032/S002)Pace Medical1996-04-26
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001)Pace Medical1995-08-28