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FDA 510(k)

4F STERILE BALLOON-LESS, CATHETER 913-28

K-Number: K791026 · 1979-06-22

ApplicantWaters Assoc., Inc.
Decision Date1979-06-22
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

4F STERILE BALLOON-LESS, CATHETER 913-28 is the device name listed in this FDA 510(k) record. The listed applicant is Waters Assoc., Inc.. It received FDA 510(k) clearance on 1979-06-22 under 510(k) number K791026. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4F STERILE BALLOON-LESS, CATHETER 913-28?

4F STERILE BALLOON-LESS, CATHETER 913-28 is a medical device that received FDA 510(k) clearance on 1979-06-22. The listed applicant is Waters Assoc., Inc.. The 510(k) number is K791026.

When did 4F STERILE BALLOON-LESS, CATHETER 913-28 receive FDA 510(k) clearance?

4F STERILE BALLOON-LESS, CATHETER 913-28 received FDA 510(k) clearance on 1979-06-22, under 510(k) number K791026.

Who is the listed applicant for 4F STERILE BALLOON-LESS, CATHETER 913-28?

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

What is the FDA product code for 4F STERILE BALLOON-LESS, CATHETER 913-28?

The FDA product code for 4F STERILE BALLOON-LESS, CATHETER 913-28 is KRB.

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Other records listing Waters Assoc., 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.

K811975MODEL 480 VARIABLE WAVELENGTH ULTRA VIOLK8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATHK801852MRM-2 OXYGEN CONSUMPTION MONITORK801431PAN-AM MYELOGRAM TRAYK791661SYSTEM CONTROLLER 720 SERIESK790145SOLVENT DELIVERY SYSTEM

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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