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FDA 510(k)

RMI DUAL FLUID IRRIGATING SYRINGE

K-Number: K964833 · 1997-02-19

ApplicantResearch Medical, Inc.
Decision Date1997-02-19
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RMI DUAL FLUID IRRIGATING SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K964833. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMI DUAL FLUID IRRIGATING SYRINGE?

RMI DUAL FLUID IRRIGATING SYRINGE is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Research Medical, Inc.. The 510(k) number is K964833.

When did RMI DUAL FLUID IRRIGATING SYRINGE receive FDA 510(k) clearance?

RMI DUAL FLUID IRRIGATING SYRINGE received FDA 510(k) clearance on 1997-02-19, under 510(k) number K964833.

Who is the listed applicant for RMI DUAL FLUID IRRIGATING SYRINGE?

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

What is the FDA product code for RMI DUAL FLUID IRRIGATING SYRINGE?

The FDA product code for RMI DUAL FLUID IRRIGATING SYRINGE is KYZ.

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Other records listing Research 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.

K970739RMI HEMOCONCENTRATOR PREFERENCE PACKK961927RMI HEMOCONCENTRACTOR TUBING SETK960098RMI INTERNAL MAMMARY ARTERY CANNULAK951344RMI HEMOCONCENTRATORK922083RMI SURGICCAL SITE VISUALIZATION WANDK920936RMI EXTERNAL CORONARY ARTERY OCCLUDER

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Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, Inc.

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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