FDA 510(k)

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT

K-Number: K840367 · 1985-12-11

Decision Date1985-12-11

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT is the device name listed in this FDA 510(k) record. The listed applicant is Smec, Inc.. It received FDA 510(k) clearance on 1985-12-11 under 510(k) number K840367. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE TRIGGER MOD OF SMEC INTRA-AORT?

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT is a medical device that received FDA 510(k) clearance on 1985-12-11. The listed applicant is Smec, Inc.. The 510(k) number is K840367.

When did PRESSURE TRIGGER MOD OF SMEC INTRA-AORT receive FDA 510(k) clearance?

PRESSURE TRIGGER MOD OF SMEC INTRA-AORT received FDA 510(k) clearance on 1985-12-11, under 510(k) number K840367.

Who is the listed applicant for PRESSURE TRIGGER MOD OF SMEC INTRA-AORT?

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

What is the FDA product code for PRESSURE TRIGGER MOD OF SMEC INTRA-AORT?

The FDA product code for PRESSURE TRIGGER MOD OF SMEC INTRA-AORT is DSP.

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Other records listing Smec, Inc. as applicant

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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.