FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CCS MODEL AV-102 IMPLANTABLE A-V DATA
K Number: K834342
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
26
Review Days
54
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Basic Information
- Device Name
- CCS MODEL AV-102 IMPLANTABLE A-V DATA
- K Number
- K834342
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardiac Control Systems, Inc.
- Date Received
- December 12, 1983
- Decision Date
- February 4, 1984
- Product Code
- DTB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
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ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
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Other Clearances by Cardiac Control Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | Dec 29, 1997 | Substantially Equivalent |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | May 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | May 3, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | May 14, 1993 | Substantially Equivalent |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | May 16, 1991 | Substantially Equivalent |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Jan 3, 1991 | Substantially Equivalent |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Sep 26, 1989 | Substantially Equivalent |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | Oct 17, 1988 | Substantially Equivalent |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | Oct 14, 1988 | Substantially Equivalent |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | Oct 6, 1988 | Substantially Equivalent |