TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1— 510(k) K884866
Substantially EquivalentOscor Medical Corp.
FDA 510(k) clearance K884866 for TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1, Substantially Equivalent on 1989-03-22. Applicant: Oscor Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Oscor Medical Corp.
- 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 Harbor, FL, US
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- K241199 — Rotatable Connector (5944RL)
More clearances from Oscor Medical Corp.
view allAdverse 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 →
Recalls naming K884866
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.