PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX— 510(k) K021856
Substantially EquivalentPorges S.A.
FDA 510(k) clearance K021856 for PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX, Substantially Equivalent on 2002-10-17. Applicant: Porges S.A.. Device class: 2.
Clearance details
- Applicant
- Porges S.A.
- Product code
- Code EYB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Plessis Robinson Cedex, FR
Recent devices under product code EYB
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- K013172 — PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.