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FDA 510(k)

DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES

K-Number: K973291 · 1997-12-19

ApplicantDynamic Technology Corp.
Decision Date1997-12-19
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Dynamic Technology Corp.. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973291. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES?

DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Dynamic Technology Corp.. The 510(k) number is K973291.

When did DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES receive FDA 510(k) clearance?

DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973291.

Who is the listed applicant for DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES?

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

What is the FDA product code for DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES?

The FDA product code for DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES is FJI.

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Other records listing Dynamic Technology 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.

K011537DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFSK990159DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111K982134DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851

Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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