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FDA 510(k)

TEF/WIRE PISTON

K-Number: K915121 · 1991-12-23

ApplicantRiver Medical, Inc.
Decision Date1991-12-23
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TEF/WIRE PISTON is the device name listed in this FDA 510(k) record. The listed applicant is River Medical, Inc.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K915121. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEF/WIRE PISTON?

TEF/WIRE PISTON is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is River Medical, Inc.. The 510(k) number is K915121.

When did TEF/WIRE PISTON receive FDA 510(k) clearance?

TEF/WIRE PISTON received FDA 510(k) clearance on 1991-12-23, under 510(k) number K915121.

Who is the listed applicant for TEF/WIRE PISTON?

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

What is the FDA product code for TEF/WIRE PISTON?

The FDA product code for TEF/WIRE PISTON is ETB.

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Other records listing River Medical, 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.

K023174DISPOSABLE TEMPORARY PACING WIREK944351SMARTDOSE IV PREFILLED INFUSION CONTAINERK944352SMARTDOSE III INFUSION CONTAINERK945298SMARTFLOW I ADMINISTRATION SETK943692SMART DOSE(TM)K932895RIVER PUMP

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Related Devices (Code: ETB)

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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