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FDA 510(k)

PERIPHERAL ATHERECTOMY SYSTEM

K-Number: K890515 · 1989-05-23

ApplicantIntensive Technology, Inc.
Decision Date1989-05-23
Product CodeDWX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL 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 1989-05-23 under 510(k) number K890515. The device is classified under product code DWX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPHERAL ATHERECTOMY SYSTEM?

PERIPHERAL ATHERECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K890515.

When did PERIPHERAL ATHERECTOMY SYSTEM receive FDA 510(k) clearance?

PERIPHERAL ATHERECTOMY SYSTEM received FDA 510(k) clearance on 1989-05-23, under 510(k) number K890515.

Who is the listed applicant for PERIPHERAL 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 PERIPHERAL ATHERECTOMY SYSTEM?

The FDA product code for PERIPHERAL ATHERECTOMY SYSTEM is DWX.

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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 SYSTEMK912664TEC ROTATING DUAL HEMOVALVEK911869IVT GUIDING CATHETERK903463IVT INTRODUCER SHEATHK904003HEMOCHRON(R) HEPARIN RESPONSE TESTK901767MODIFIED IVT PERIPHERAL ATHERECTOMY

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Related Devices (Code: DWX)

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.

K121415MOLLRING MULTITASCLeMaitre Vascular, Inc.K032105ENDOHELIX ENDARTERECTOMY DEVICEEndarx, Inc.K020925CARBODISSECTING ENDOSCOPEEndo Surgical Devices, Inc.K003719VASCULAR ARCHITECTS PERISCOPE DEVICEVascular Architects, Inc.K950813MOLLRING CUTTERCardio Vascular Concepts, Inc.K933498EXTERNAL VEIN STRIPPERApplied Medical Resources

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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