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FDA 510(k)

ARROW-TREROTOLA PTD CATHETER

K-Number: K970080 · 1997-07-25

ApplicantArrow Intl., Inc.
Decision Date1997-07-25
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW-TREROTOLA PTD CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K970080. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARROW-TREROTOLA PTD CATHETER?

ARROW-TREROTOLA PTD CATHETER is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K970080.

When did ARROW-TREROTOLA PTD CATHETER receive FDA 510(k) clearance?

ARROW-TREROTOLA PTD CATHETER received FDA 510(k) clearance on 1997-07-25, under 510(k) number K970080.

Who is the listed applicant for ARROW-TREROTOLA PTD CATHETER?

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

What is the FDA product code for ARROW-TREROTOLA PTD CATHETER?

The FDA product code for ARROW-TREROTOLA PTD CATHETER is MCW.

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Other records listing Arrow Intl., Inc. as applicant

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Related Devices (Code: MCW)

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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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