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FDA 510(k)

SHELHIGH BIORING

K-Number: K023940 · 2003-06-04

ApplicantShelhigh, Inc.
Decision Date2003-06-04
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHELHIGH BIORING is the device name listed in this FDA 510(k) record. The listed applicant is Shelhigh, Inc.. It received FDA 510(k) clearance on 2003-06-04 under 510(k) number K023940. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHELHIGH BIORING?

SHELHIGH BIORING is a medical device that received FDA 510(k) clearance on 2003-06-04. The listed applicant is Shelhigh, Inc.. The 510(k) number is K023940.

When did SHELHIGH BIORING receive FDA 510(k) clearance?

SHELHIGH BIORING received FDA 510(k) clearance on 2003-06-04, under 510(k) number K023940.

Who is the listed applicant for SHELHIGH BIORING?

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

What is the FDA product code for SHELHIGH BIORING?

The FDA product code for SHELHIGH BIORING is KRH.

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Other records listing Shelhigh, Inc. as applicant

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.

K032893SHELHIGH NO-REACT BIOCUFFK982101SHELHIGH NO-REACT DURA SHIELDK991567SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.K982810SHELHIGH NO-REACT VASCUPATCHK981756SHELHIGH NO-REACT PNEUMOPLEDGETSK974914SHELHIGH NO-REACT PERICARDIAL PATCHES

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Related Devices (Code: KRH)

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.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

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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