SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023— 510(k) K041453
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K041453 for SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023, Substantially Equivalent on 2004-07-22. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code DWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Recalls naming K041453
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 K041453.
Data sourced from openFDA. This site is unofficial and independent of the FDA.