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FDA 510(k)

HIGH PRESSURE INJECTION LINES

K-Number: K963749 · 1996-12-17

ApplicantMaxxim Medical
Decision Date1996-12-17
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HIGH PRESSURE INJECTION LINES is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 1996-12-17 under 510(k) number K963749. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH PRESSURE INJECTION LINES?

HIGH PRESSURE INJECTION LINES is a medical device that received FDA 510(k) clearance on 1996-12-17. The listed applicant is Maxxim Medical. The 510(k) number is K963749.

When did HIGH PRESSURE INJECTION LINES receive FDA 510(k) clearance?

HIGH PRESSURE INJECTION LINES received FDA 510(k) clearance on 1996-12-17, under 510(k) number K963749.

Who is the listed applicant for HIGH PRESSURE INJECTION LINES?

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

What is the FDA product code for HIGH PRESSURE INJECTION LINES?

The FDA product code for HIGH PRESSURE INJECTION LINES is DTL.

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Related Devices (Code: DTL)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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