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FDA 510(k)

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR

K-Number: K882380 · 1988-10-06

ApplicantScimed Life Systems, Inc.
Decision Date1988-10-06
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR 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 1988-10-06 under 510(k) number K882380. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR?

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K882380.

When did SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR receive FDA 510(k) clearance?

SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR received FDA 510(k) clearance on 1988-10-06, under 510(k) number K882380.

Who is the listed applicant for SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR?

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 MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR?

The FDA product code for SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR is DTN.

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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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Related Devices (Code: DTN)

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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