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FDA 510(k)

HEMOSTASIS VALVE AND TUBING SET

K-Number: K930194 · 1993-09-22

ApplicantOpticon Medical, Inc.
Decision Date1993-09-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMOSTASIS VALVE AND TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Opticon Medical, Inc.. It received FDA 510(k) clearance on 1993-09-22 under 510(k) number K930194. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSTASIS VALVE AND TUBING SET?

HEMOSTASIS VALVE AND TUBING SET is a medical device that received FDA 510(k) clearance on 1993-09-22. The listed applicant is Opticon Medical, Inc.. The 510(k) number is K930194.

When did HEMOSTASIS VALVE AND TUBING SET receive FDA 510(k) clearance?

HEMOSTASIS VALVE AND TUBING SET received FDA 510(k) clearance on 1993-09-22, under 510(k) number K930194.

Who is the listed applicant for HEMOSTASIS VALVE AND TUBING SET?

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

What is the FDA product code for HEMOSTASIS VALVE AND TUBING SET?

The FDA product code for HEMOSTASIS VALVE AND TUBING SET is DYB.

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Other records listing Opticon Medical, 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.

K033830OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000K023090OPTION-VF URINARY CATHETER, FV14218K970716OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGEK904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTEK895955LOPER CELIAC PLEXUS BLOCK CATHETER KITK895476OPTION EPIDURAL CATHETERS

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, 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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