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FDA 510(k)

MINI VP1 (PL67_F); MINI VP1 (PL61_F)

K-Number: K250495 · 2025-08-01

ApplicantAvizor S.A.
Decision Date2025-08-01
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MINI VP1 (PL67_F); MINI VP1 (PL61_F) is the device name listed in this FDA 510(k) record. The listed applicant is Avizor S.A.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250495. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI VP1 (PL67_F); MINI VP1 (PL61_F)?

MINI VP1 (PL67_F); MINI VP1 (PL61_F) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Avizor S.A.. The 510(k) number is K250495.

When did MINI VP1 (PL67_F); MINI VP1 (PL61_F) receive FDA 510(k) clearance?

MINI VP1 (PL67_F); MINI VP1 (PL61_F) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250495.

Who is the listed applicant for MINI VP1 (PL67_F); MINI VP1 (PL61_F)?

The FDA 510(k) record lists Avizor S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI VP1 (PL67_F); MINI VP1 (PL61_F)?

The FDA product code for MINI VP1 (PL67_F); MINI VP1 (PL61_F) is LRX.

Related Devices (Code: LRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.