INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610— 510(k) K971775
Substantially EquivalentCardiac Control Systems, Inc.
FDA 510(k) clearance K971775 for INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610, Substantially Equivalent on 1997-12-29. Applicant: Cardiac Control Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiac Control Systems, Inc.
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Coast, FL, US
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More clearances from Cardiac Control Systems, Inc.
view all- 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
- K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
Adverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
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.