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FDA 510(k)

HOSPAL DIALYSATE FOR C.A.V.H.D.

K-Number: K872857 · 1987-10-05

ApplicantDelmed, Inc.
Decision Date1987-10-05
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOSPAL DIALYSATE FOR C.A.V.H.D. is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1987-10-05 under 510(k) number K872857. 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 C.A.V.H.D.?

HOSPAL DIALYSATE FOR C.A.V.H.D. is a medical device that received FDA 510(k) clearance on 1987-10-05. The listed applicant is Delmed, Inc.. The 510(k) number is K872857.

When did HOSPAL DIALYSATE FOR C.A.V.H.D. receive FDA 510(k) clearance?

HOSPAL DIALYSATE FOR C.A.V.H.D. received FDA 510(k) clearance on 1987-10-05, under 510(k) number K872857.

Who is the listed applicant for HOSPAL DIALYSATE FOR C.A.V.H.D.?

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

What is the FDA product code for HOSPAL DIALYSATE FOR C.A.V.H.D.?

The FDA product code for HOSPAL DIALYSATE FOR C.A.V.H.D. is KPO.

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Other records listing Delmed, 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.

K895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

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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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