HYPERFLEX FLEXIBLE GUIDEWIRES— 510(k) K941711
Substantially EquivalentLinvatec Corp.
FDA 510(k) clearance K941711 for HYPERFLEX FLEXIBLE GUIDEWIRES, Substantially Equivalent on 1994-08-26. Applicant: Linvatec Corp.. Device class: 1.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code LXH
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code LXH
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- K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
- K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
Adverse events under product code LXH
product code LXH- Death
- 11
- Injury
- 2,218
- Malfunction
- 31,318
- Total
- 33,547
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.