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FDA 510(k)

RAPID EXCHANGE TAPERTOME

K-Number: K002802 · 2000-10-05

ApplicantBoston Scientific Corp
Decision Date2000-10-05
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RAPID EXCHANGE TAPERTOME is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2000-10-05 under 510(k) number K002802. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID EXCHANGE TAPERTOME?

RAPID EXCHANGE TAPERTOME is a medical device that received FDA 510(k) clearance on 2000-10-05. The listed applicant is Boston Scientific Corp. The 510(k) number is K002802.

When did RAPID EXCHANGE TAPERTOME receive FDA 510(k) clearance?

RAPID EXCHANGE TAPERTOME received FDA 510(k) clearance on 2000-10-05, under 510(k) number K002802.

Who is the listed applicant for RAPID EXCHANGE TAPERTOME?

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

What is the FDA product code for RAPID EXCHANGE TAPERTOME?

The FDA product code for RAPID EXCHANGE TAPERTOME is KNS.

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Other records listing Boston Scientific Corp as applicant

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Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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