Atlas FDA

CCS MODEL AV-102 IMPLANTABLE A-V DATA

FDA 510(k) clearance K834342 · decided 1984-02-04

Clearance details

K-number
K834342
Device name
CCS MODEL AV-102 IMPLANTABLE A-V DATA
Applicant
Cardiac Control Systems, Inc.
Decision
Substantially Equivalent
Date received
1983-12-12
Decision date
1984-02-04
Days to decision
54 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, 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
POLY-SAFE(TM) A-TRACK(TM) PACING LEADS (P890039/S016)Cardiac Control Systems, Inc.1998-11-09
MAESTRO(R) II MODEL 534 PACEMAKER SYSTEM (P860027/S012)Cardiac Control Systems, Inc.1997-07-29
MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S011)Cardiac Control Systems, Inc.1996-07-09
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S015)Cardiac Control Systems, Inc.1996-07-09
MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S010)Cardiac Control Systems, Inc.1995-09-26
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S014)Cardiac Control Systems, Inc.1995-05-16
CCS MODEL 325 PACEMAKER SYSTEM (P890039/S012)Cardiac Control Systems, Inc.1994-12-02
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S013)Cardiac Control Systems, Inc.1994-04-29