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FDA 510(k)

PRESSURE BARRIER KIT CAT. NO. PBK-3

K-Number: K873802 · 1987-11-06

ApplicantAmerican Omni Medical, Inc.
Decision Date1987-11-06
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE BARRIER KIT CAT. NO. PBK-3 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 1987-11-06 under 510(k) number K873802. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE BARRIER KIT CAT. NO. PBK-3?

PRESSURE BARRIER KIT CAT. NO. PBK-3 is a medical device that received FDA 510(k) clearance on 1987-11-06. The listed applicant is American Omni Medical, Inc.. The 510(k) number is K873802.

When did PRESSURE BARRIER KIT CAT. NO. PBK-3 receive FDA 510(k) clearance?

PRESSURE BARRIER KIT CAT. NO. PBK-3 received FDA 510(k) clearance on 1987-11-06, under 510(k) number K873802.

Who is the listed applicant for PRESSURE BARRIER KIT CAT. NO. PBK-3?

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 PRESSURE BARRIER KIT CAT. NO. PBK-3?

The FDA product code for PRESSURE BARRIER KIT CAT. NO. PBK-3 is DXS.

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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: DXS)

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.

K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology IncorporatedK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, Inc.K852232PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, 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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