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FDA 510(k)

CONVOY ADVANCED DELIVERY SHEATH KIT

K-Number: K013866 · 2001-12-14

ApplicantBoston Scientific
Decision Date2001-12-14
Product CodeDBY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CONVOY ADVANCED DELIVERY SHEATH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2001-12-14 under 510(k) number K013866. The device is classified under product code DBY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVOY ADVANCED DELIVERY SHEATH KIT?

CONVOY ADVANCED DELIVERY SHEATH KIT is a medical device that received FDA 510(k) clearance on 2001-12-14. The listed applicant is Boston Scientific. The 510(k) number is K013866.

When did CONVOY ADVANCED DELIVERY SHEATH KIT receive FDA 510(k) clearance?

CONVOY ADVANCED DELIVERY SHEATH KIT received FDA 510(k) clearance on 2001-12-14, under 510(k) number K013866.

Who is the listed applicant for CONVOY ADVANCED DELIVERY SHEATH KIT?

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

What is the FDA product code for CONVOY ADVANCED DELIVERY SHEATH KIT?

The FDA product code for CONVOY ADVANCED DELIVERY SHEATH KIT is DBY.

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Related Devices (Code: DBY)

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.

K022067CONVOY ADVANCED DELIVERY SHEATHBoston ScientificK013919TORFLEX TRANSSEPTAL GUIDING SHEATHBaylis Medical Co., Inc.K013304BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCERBecton Dickinson Infusion Therapy Systems, Inc.K013282GORE INTRODUCER SHEATHW. L. Gore & Associates, Inc.K771144RHODAMINE-CONJUGATED ANTISERUMKent Laboratories, 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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