MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS— 510(k) K880326
Substantially EquivalentCardiac Control Systems, Inc.
FDA 510(k) clearance K880326 for MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS, Substantially Equivalent on 1988-04-11. Applicant: Cardiac Control Systems, Inc.. Device class: 3.
Clearance details
- Applicant
- Cardiac Control Systems, Inc.
- Product code
- Code DXY
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Coast, FL, US
Recent devices under product code DXY
view all- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
More clearances from Cardiac Control Systems, Inc.
view all- K971775 — INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
- K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
- K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
- K923868 — CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
- K905824 — MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.