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FDA 510(k)

TERUMO PRESSURE ISOLATOR

K-Number: K092644 · 2009-12-10

ApplicantTerumo Cardiovascular Systems Corp.
Decision Date2009-12-10
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TERUMO PRESSURE ISOLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corp.. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K092644. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO PRESSURE ISOLATOR?

TERUMO PRESSURE ISOLATOR is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Terumo Cardiovascular Systems Corp.. The 510(k) number is K092644.

When did TERUMO PRESSURE ISOLATOR receive FDA 510(k) clearance?

TERUMO PRESSURE ISOLATOR received FDA 510(k) clearance on 2009-12-10, under 510(k) number K092644.

Who is the listed applicant for TERUMO PRESSURE ISOLATOR?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO PRESSURE ISOLATOR?

The FDA product code for TERUMO PRESSURE ISOLATOR is DRS.

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Related Devices (Code: DRS)

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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