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FDA 510(k)

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

K-Number: K010610 · 2001-03-27

ApplicantBoston Scientific Corp
Decision Date2001-03-27
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 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 2001-03-27 under 510(k) number K010610. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527?

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Boston Scientific Corp. The 510(k) number is K010610.

When did RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 receive FDA 510(k) clearance?

RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 received FDA 510(k) clearance on 2001-03-27, under 510(k) number K010610.

Who is the listed applicant for RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527?

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 BIOPSY CAP AND LOCKING DEVICE #4526 & 4527?

The FDA product code for RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 is ODC.

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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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