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FDA 510(k)

SCANLAN (TM) VEIN/GRAFT HOLDER

K-Number: K864919 · 1987-01-12

ApplicantScanlan Intl., Inc.
Decision Date1987-01-12
Product CodeKPK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCANLAN (TM) VEIN/GRAFT HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Scanlan Intl., Inc.. It received FDA 510(k) clearance on 1987-01-12 under 510(k) number K864919. The device is classified under product code KPK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANLAN (TM) VEIN/GRAFT HOLDER?

SCANLAN (TM) VEIN/GRAFT HOLDER is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Scanlan Intl., Inc.. The 510(k) number is K864919.

When did SCANLAN (TM) VEIN/GRAFT HOLDER receive FDA 510(k) clearance?

SCANLAN (TM) VEIN/GRAFT HOLDER received FDA 510(k) clearance on 1987-01-12, under 510(k) number K864919.

Who is the listed applicant for SCANLAN (TM) VEIN/GRAFT HOLDER?

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

What is the FDA product code for SCANLAN (TM) VEIN/GRAFT HOLDER?

The FDA product code for SCANLAN (TM) VEIN/GRAFT HOLDER is KPK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Scanlan Intl., 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.

K960372SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEMK945474SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERK911184SCANLAN/TAHERI VALVULOTOMEK864920SCANLAN (TM) INSTRUMENT TRAYK851825SCANLAN TUNNELER, SHEATH & TIPK841521SCANLAN ENDARSECTOR

View all 19 devices →

Related Devices (Code: KPK)

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.

K971966CORONARY VEIN GRAFT TAG MARKERMed-Edge, Inc.K895369VOSS GRAFT MARKERVoss Medical ProductsK864101COOK (R) VEIN GRAFT RING MARKERSCook, Inc.K801637FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.C.R. Bard, Inc.K770802MARKERS, STAINLESS STEELCardio-Surgical, 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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