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FDA 510(k)

4-LEAD IRRIGATION SET

K-Number: K942101 · 1994-09-30

ApplicantDouglas Medical Products Corp.
Decision Date1994-09-30
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4-LEAD IRRIGATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Douglas Medical Products Corp.. It received FDA 510(k) clearance on 1994-09-30 under 510(k) number K942101. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4-LEAD IRRIGATION SET?

4-LEAD IRRIGATION SET is a medical device that received FDA 510(k) clearance on 1994-09-30. The listed applicant is Douglas Medical Products Corp.. The 510(k) number is K942101.

When did 4-LEAD IRRIGATION SET receive FDA 510(k) clearance?

4-LEAD IRRIGATION SET received FDA 510(k) clearance on 1994-09-30, under 510(k) number K942101.

Who is the listed applicant for 4-LEAD IRRIGATION SET?

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

What is the FDA product code for 4-LEAD IRRIGATION SET?

The FDA product code for 4-LEAD IRRIGATION SET is HRX.

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Other records listing Douglas Medical Products Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961155SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908K954428SOLOPICC 24 (60CM) 20GA CATHETERK94162840 MICRON BLOOD TRANSFUSION FILTERK941453CHECK VALVE SOLUTION SETK930854SOLUTION SET WITH .2 MICRON FILTERK932637SUBCUTANEOUS INFUSION SET

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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