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FDA 510(k)

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P

K-Number: K960970 · 1996-12-03

ApplicantPossis Medical, Inc.
Decision Date1996-12-03
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P is the device name listed in this FDA 510(k) record. The listed applicant is Possis Medical, Inc.. It received FDA 510(k) clearance on 1996-12-03 under 510(k) number K960970. 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 POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P?

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P is a medical device that received FDA 510(k) clearance on 1996-12-03. The listed applicant is Possis Medical, Inc.. The 510(k) number is K960970.

When did POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P receive FDA 510(k) clearance?

POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P received FDA 510(k) clearance on 1996-12-03, under 510(k) number K960970.

Who is the listed applicant for POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P?

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

What is the FDA product code for POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P?

The FDA product code for POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P is MCW.

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Other records listing Possis 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.

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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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