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FDA 510(k)

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201

K-Number: K003551 · 2001-07-11

ApplicantJostra AG
Decision Date2001-07-11
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 is the device name listed in this FDA 510(k) record. The listed applicant is Jostra AG. It received FDA 510(k) clearance on 2001-07-11 under 510(k) number K003551. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201?

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 is a medical device that received FDA 510(k) clearance on 2001-07-11. The listed applicant is Jostra AG. The 510(k) number is K003551.

When did VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 receive FDA 510(k) clearance?

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 received FDA 510(k) clearance on 2001-07-11, under 510(k) number K003551.

Who is the listed applicant for VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201?

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

What is the FDA product code for VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201?

The FDA product code for VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 is DTN.

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Other records listing Jostra AG as applicant

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Related Devices (Code: DTN)

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.

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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.

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