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FDA 510(k)

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM

K-Number: K922970 · 1993-01-13

ApplicantIntensive Technology, Inc.
Decision Date1993-01-13
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM 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 1993-01-13 under 510(k) number K922970. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM?

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1993-01-13. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K922970.

When did INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM receive FDA 510(k) clearance?

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM received FDA 510(k) clearance on 1993-01-13, under 510(k) number K922970.

Who is the listed applicant for INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM?

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 INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM?

The FDA product code for INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM is MCW.

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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.

K912664TEC ROTATING DUAL HEMOVALVEK911869IVT GUIDING CATHETERK903463IVT INTRODUCER SHEATHK904003HEMOCHRON(R) HEPARIN RESPONSE TESTK901767MODIFIED IVT PERIPHERAL ATHERECTOMYK896403MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

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Related Devices (Code: MCW)

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.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

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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