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FDA 510(k)

SIMPSON PERIPHERAL ATHEROCATH(TM)

K-Number: K871011 · 1987-05-14

ApplicantDevices For Vascular Intervention, Inc.
Decision Date1987-05-14
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIMPSON PERIPHERAL ATHEROCATH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Devices For Vascular Intervention, Inc.. It received FDA 510(k) clearance on 1987-05-14 under 510(k) number K871011. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPSON PERIPHERAL ATHEROCATH(TM)?

SIMPSON PERIPHERAL ATHEROCATH(TM) is a medical device that received FDA 510(k) clearance on 1987-05-14. The listed applicant is Devices For Vascular Intervention, Inc.. The 510(k) number is K871011.

When did SIMPSON PERIPHERAL ATHEROCATH(TM) receive FDA 510(k) clearance?

SIMPSON PERIPHERAL ATHEROCATH(TM) received FDA 510(k) clearance on 1987-05-14, under 510(k) number K871011.

Who is the listed applicant for SIMPSON PERIPHERAL ATHEROCATH(TM)?

The FDA 510(k) record lists Devices For Vascular Intervention, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPSON PERIPHERAL ATHEROCATH(TM)?

The FDA product code for SIMPSON PERIPHERAL ATHEROCATH(TM) is LIT.

Related Clinical Trials

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.

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Other records listing Devices For Vascular Intervention, 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.

K935929MICROTRACKK920707HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLERK914422DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVEK911678ROTATING HEMOSTATIC VALVEK910205LP-60 LOW PRESSURE INFLATION DEVICEK901601HOLLOW MOTOR DRIVE UNIT

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Related Devices (Code: LIT)

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.

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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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