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FDA 510(k)

TEC ROTATING DUAL HEMOVALVE

K-Number: K912664 · 1992-08-24

ApplicantIntensive Technology, Inc.
Decision Date1992-08-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEC ROTATING DUAL HEMOVALVE is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1992-08-24 under 510(k) number K912664. 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 TEC ROTATING DUAL HEMOVALVE?

TEC ROTATING DUAL HEMOVALVE is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K912664.

When did TEC ROTATING DUAL HEMOVALVE receive FDA 510(k) clearance?

TEC ROTATING DUAL HEMOVALVE received FDA 510(k) clearance on 1992-08-24, under 510(k) number K912664.

Who is the listed applicant for TEC ROTATING DUAL HEMOVALVE?

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

What is the FDA product code for TEC ROTATING DUAL HEMOVALVE?

The FDA product code for TEC ROTATING DUAL HEMOVALVE is DYB.

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Other records listing Intensive Technology, 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.

K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEMK911869IVT GUIDING CATHETERK903463IVT INTRODUCER SHEATHK904003HEMOCHRON(R) HEPARIN RESPONSE TESTK901767MODIFIED IVT PERIPHERAL ATHERECTOMYK896403MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

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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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