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FDA 510(k)

LO-PROFILE EXTENSION SET

K-Number: K915560 · 1992-05-14

ApplicantDouglas Medical Products Corp.
Decision Date1992-05-14
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LO-PROFILE EXTENSION 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 1992-05-14 under 510(k) number K915560. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LO-PROFILE EXTENSION SET?

LO-PROFILE EXTENSION SET is a medical device that received FDA 510(k) clearance on 1992-05-14. The listed applicant is Douglas Medical Products Corp.. The 510(k) number is K915560.

When did LO-PROFILE EXTENSION SET receive FDA 510(k) clearance?

LO-PROFILE EXTENSION SET received FDA 510(k) clearance on 1992-05-14, under 510(k) number K915560.

Who is the listed applicant for LO-PROFILE EXTENSION 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 LO-PROFILE EXTENSION SET?

The FDA product code for LO-PROFILE EXTENSION SET is FPK.

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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 FILTERK9421014-LEAD IRRIGATION SETK941453CHECK VALVE SOLUTION SETK930854SOLUTION SET WITH .2 MICRON FILTER

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Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.

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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