PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR— 510(k) K033130
Substantially EquivalentOsypka Medical, Inc.
FDA 510(k) clearance K033130 for PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR, Substantially Equivalent on 2003-10-31. Applicant: Osypka Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osypka Medical, Inc.
- Product code
- Code DTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- La Jolla, CA, US
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- K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES
Adverse events under product code DTE
product code DTE- Death
- 18
- Injury
- 247
- Malfunction
- 4,603
- Total
- 4,868
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.