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FDA 510(k)

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA

K-Number: K102101 · 2011-01-26

ApplicantSurgivision, Inc.
Decision Date2011-01-26
Product CodeHCD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Surgivision, Inc.. It received FDA 510(k) clearance on 2011-01-26 under 510(k) number K102101. The device is classified under product code HCD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA is a medical device that received FDA 510(k) clearance on 2011-01-26. The listed applicant is Surgivision, Inc.. The 510(k) number is K102101.

When did SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA receive FDA 510(k) clearance?

SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA received FDA 510(k) clearance on 2011-01-26, under 510(k) number K102101.

Who is the listed applicant for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

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

What is the FDA product code for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA?

The FDA product code for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA is HCD.

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Other records listing Surgivision, Inc. as applicant

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Related Devices (Code: HCD)

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

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

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