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FDA 510(k)

SARNS EVACUPLEGE CATHETER

K-Number: K853128 · 1985-10-17

Applicant3M Health Care, Sarns
Decision Date1985-10-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SARNS EVACUPLEGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is 3M Health Care, Sarns. It received FDA 510(k) clearance on 1985-10-17 under 510(k) number K853128. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARNS EVACUPLEGE CATHETER?

SARNS EVACUPLEGE CATHETER is a medical device that received FDA 510(k) clearance on 1985-10-17. The listed applicant is 3M Health Care, Sarns. The 510(k) number is K853128.

When did SARNS EVACUPLEGE CATHETER receive FDA 510(k) clearance?

SARNS EVACUPLEGE CATHETER received FDA 510(k) clearance on 1985-10-17, under 510(k) number K853128.

Who is the listed applicant for SARNS EVACUPLEGE CATHETER?

The FDA 510(k) record lists 3M Health Care, Sarns as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SARNS EVACUPLEGE CATHETER?

The FDA product code for SARNS EVACUPLEGE CATHETER is DWF.

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Other records listing 3M Health Care, Sarns as applicant

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Related Devices (Code: DWF)

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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