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FDA 510(k)

HOSPAL DIALYSATE FOR CAVHD

K-Number: K861156 · 1986-09-23

ApplicantHospal Medical Corp.
Decision Date1986-09-23
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOSPAL DIALYSATE FOR CAVHD is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1986-09-23 under 510(k) number K861156. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOSPAL DIALYSATE FOR CAVHD?

HOSPAL DIALYSATE FOR CAVHD is a medical device that received FDA 510(k) clearance on 1986-09-23. The listed applicant is Hospal Medical Corp.. The 510(k) number is K861156.

When did HOSPAL DIALYSATE FOR CAVHD receive FDA 510(k) clearance?

HOSPAL DIALYSATE FOR CAVHD received FDA 510(k) clearance on 1986-09-23, under 510(k) number K861156.

Who is the listed applicant for HOSPAL DIALYSATE FOR CAVHD?

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

What is the FDA product code for HOSPAL DIALYSATE FOR CAVHD?

The FDA product code for HOSPAL DIALYSATE FOR CAVHD is KPO.

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Other records listing Hospal Medical 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.

K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZERK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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Related Devices (Code: KPO)

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.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

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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