FDA 510(k)

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

K-Nummer: K252316 · 2025-08-19

Entscheidungsdatum2025-08-19

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2025-08-19 under 510(k) number K252316. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is a medical device that received FDA 510(k) clearance on 2025-08-19. The listed applicant is Venclose, Inc.. The 510(k) number is K252316.

When did Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) receive FDA 510(k) clearance?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) received FDA 510(k) clearance on 2025-08-19, under 510(k) number K252316.

Who is the listed applicant for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA 510(k) record lists Venclose, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is GEI.

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Weitere Einträge mit Venclose, Inc. als Antragsteller

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Verwandte Geräte (Code: GEI)

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Offizielle Quelle

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