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FDA 510(k)

SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100

K-Number: K861428 · 1986-06-26

ApplicantAmerican Omni Medical, Inc.
Decision Date1986-06-26
Product CodeDWD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 is the device name listed in this FDA 510(k) record. The listed applicant is American Omni Medical, Inc.. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K861428. The device is classified under product code DWD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100?

SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K861428.

When did SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 receive FDA 510(k) clearance?

SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 received FDA 510(k) clearance on 1986-06-26, under 510(k) number K861428.

Who is the listed applicant for SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100?

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

What is the FDA product code for SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100?

The FDA product code for SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 is DWD.

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Other records listing American Omni 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.

K922781FLOW CONROL VALVEK922356FLOW CONTROL VALVE, CAT. NO. ACV-38K900672PREBYPASS FILTER, CAT. NO. FPB-5K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700K873316BUBBLE TRAP-FILTER CAT. NO B180F37

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Related Devices (Code: DWD)

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.

K992657IBC VRV, MODEL 1350International Biophysics Corp.K920077NIKKISO NK PUMPInternational Medical Products, Inc.K915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.Bd Becton Dickinson Vacutainer Systems PreanalyticK915482B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PTBd Becton Dickinson Vacutainer Systems PreanalyticK915481B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINTBd Becton Dickinson Vacutainer Systems PreanalyticK905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.Baxter Bentley Laboratories, 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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