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FDA 510(k)

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007

K-Number: K032372 · 2003-08-15

ApplicantNucletron Corporation
Decision Date2003-08-15
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron Corporation. It received FDA 510(k) clearance on 2003-08-15 under 510(k) number K032372. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007?

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 is a medical device that received FDA 510(k) clearance on 2003-08-15. The listed applicant is Nucletron Corporation. The 510(k) number is K032372.

When did NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 receive FDA 510(k) clearance?

NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 received FDA 510(k) clearance on 2003-08-15, under 510(k) number K032372.

Who is the listed applicant for NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007?

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

What is the FDA product code for NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007?

The FDA product code for NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007 is JAQ.

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Related Devices (Code: JAQ)

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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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