FDA 510(k)

VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM

K-Number: K090371 · 2009-05-01

Decision Date2009-05-01

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K090371. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM?

VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is STERIS Corporation. The 510(k) number is K090371.

When did VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM receive FDA 510(k) clearance?

VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM received FDA 510(k) clearance on 2009-05-01, under 510(k) number K090371.

Who is the listed applicant for VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM?

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

What is the FDA product code for VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM?

The FDA product code for VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM is KCT.

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Official Source

View on FDA Database →

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