ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE— 510(k) K890785
Substantially EquivalentCardiac Pacemakers, Inc.
FDA 510(k) clearance K890785 for ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE, Substantially Equivalent on 1989-03-10. Applicant: Cardiac Pacemakers, Inc.. Device class: 3.
Clearance details
- Applicant
- Cardiac Pacemakers, 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
- St. Paul, MN, 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 Pacemakers, Inc.
view allAdverse 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.