FDA 510(k)

ALIEN RX MICRO CANNULA, MODEL 4530

K-Number: K010993 · 2001-04-30

Decision Date2001-04-30

Product CodeODD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ALIEN RX MICRO CANNULA, MODEL 4530 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 2001-04-30 under 510(k) number K010993. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIEN RX MICRO CANNULA, MODEL 4530?

ALIEN RX MICRO CANNULA, MODEL 4530 is a medical device that received FDA 510(k) clearance on 2001-04-30. The listed applicant is Boston Scientific Corp. The 510(k) number is K010993.

When did ALIEN RX MICRO CANNULA, MODEL 4530 receive FDA 510(k) clearance?

ALIEN RX MICRO CANNULA, MODEL 4530 received FDA 510(k) clearance on 2001-04-30, under 510(k) number K010993.

Who is the listed applicant for ALIEN RX MICRO CANNULA, MODEL 4530?

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 ALIEN RX MICRO CANNULA, MODEL 4530?

The FDA product code for ALIEN RX MICRO CANNULA, MODEL 4530 is ODD.

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Related Devices (Code: ODD)

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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.