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FDA 510(k)

EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189

K-Number: K013789 · 2001-12-06

ApplicantBoston Scientific, Target
Decision Date2001-12-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific, Target. It received FDA 510(k) clearance on 2001-12-06 under 510(k) number K013789. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189?

EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Boston Scientific, Target. The 510(k) number is K013789.

When did EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 receive FDA 510(k) clearance?

EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 received FDA 510(k) clearance on 2001-12-06, under 510(k) number K013789.

Who is the listed applicant for EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189?

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

What is the FDA product code for EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189?

The FDA product code for EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 is DQY.

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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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