Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT

K-Number: K963203 · 1997-03-25

ApplicantBaxter Healthcare Corp
Decision Date1997-03-25
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1997-03-25 under 510(k) number K963203. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT?

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT is a medical device that received FDA 510(k) clearance on 1997-03-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K963203.

When did BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT receive FDA 510(k) clearance?

BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT received FDA 510(k) clearance on 1997-03-25, under 510(k) number K963203.

Who is the listed applicant for BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT?

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

What is the FDA product code for BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT?

The FDA product code for BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT is KDI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Healthcare 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.

K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

View all 504 devices →

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius 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.

↑