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FDA 510(k)

SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH

K-Number: K910155 · 1991-02-07

ApplicantScimed Life Systems, Inc.
Decision Date1991-02-07
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1991-02-07 under 510(k) number K910155. 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 SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH?

SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH is a medical device that received FDA 510(k) clearance on 1991-02-07. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K910155.

When did SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH receive FDA 510(k) clearance?

SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH received FDA 510(k) clearance on 1991-02-07, under 510(k) number K910155.

Who is the listed applicant for SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH?

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

What is the FDA product code for SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH?

The FDA product code for SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH is LIT.

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Other records listing Scimed Life Systems, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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