FDA 510(k)

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP

K-Number: K952663 · 1995-07-14

ApplicantDistronic Sterile Products, Inc.

Decision Date1995-07-14

Product CodeFPK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Distronic Sterile Products, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K952663. 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 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP?

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Distronic Sterile Products, Inc.. The 510(k) number is K952663.

When did 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP receive FDA 510(k) clearance?

60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP received FDA 510(k) clearance on 1995-07-14, under 510(k) number K952663.

Who is the listed applicant for 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP?

The FDA 510(k) record lists Distronic Sterile Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP?

The FDA product code for 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP is FPK.

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Other records listing Distronic Sterile Products, Inc. as applicant

K955709WINGED & SUBCUTANEOUS INFUSION SETS K955732VENTED SOLUTION SET K954984MINIBORE STOPCOCK SET K954983EXTENSION SET WITH CHECK VALVE K952664SOLUTION ADMINISTRATION SET K950597CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE

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Related Devices (Code: FPK)

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 Minimed K041178EMPOWER 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.