ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825— 510(k) K011980
Substantially EquivalentPace Medical
FDA 510(k) clearance K011980 for ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825, Substantially Equivalent on 2001-09-12. Applicant: Pace Medical. Device class: 2.
Clearance details
- Applicant
- Pace Medical
- 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
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code DTE
view allMore clearances from Pace Medical
view all- K012392 — DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
- K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
- K002496 — MODEL 4815 ADAPTER
- K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER
- K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
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.