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FDA 510(k)

LOW VOLUME EXTENSION SET

K-Number: K864395 · 1986-12-16

ApplicantPanamedix, Inc.
Decision Date1986-12-16
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LOW VOLUME EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Panamedix, Inc.. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K864395. 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 LOW VOLUME EXTENSION SET?

LOW VOLUME EXTENSION SET is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Panamedix, Inc.. The 510(k) number is K864395.

When did LOW VOLUME EXTENSION SET receive FDA 510(k) clearance?

LOW VOLUME EXTENSION SET received FDA 510(k) clearance on 1986-12-16, under 510(k) number K864395.

Who is the listed applicant for LOW VOLUME EXTENSION SET?

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

What is the FDA product code for LOW VOLUME EXTENSION SET?

The FDA product code for LOW VOLUME EXTENSION SET is FPK.

Related Clinical Trials

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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Other records listing Panamedix, Inc. 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.

K871848NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMPK871843TWO FLUID W/CHECK VALVEK871842TWO FLUID I.V. SETSK871841THREE FLUID I.V. SETSK865051GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP

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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