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FDA 510(k)

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15

K-Number: K871471 · 1987-06-12

ApplicantTravenol Laboratories, S.A.
Decision Date1987-06-12
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1987-06-12 under 510(k) number K871471. 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 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15?

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 is a medical device that received FDA 510(k) clearance on 1987-06-12. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K871471.

When did CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 receive FDA 510(k) clearance?

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 received FDA 510(k) clearance on 1987-06-12, under 510(k) number K871471.

Who is the listed applicant for CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15?

The FDA product code for CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 is FJI.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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

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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