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FDA 510(k)

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

K-Number: K072364 · 2007-09-19

ApplicantPulsion Medical Systems AG
Decision Date2007-09-19
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Pulsion Medical Systems AG. It received FDA 510(k) clearance on 2007-09-19 under 510(k) number K072364. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES?

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-09-19. The listed applicant is Pulsion Medical Systems AG. The 510(k) number is K072364.

When did PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES receive FDA 510(k) clearance?

PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES received FDA 510(k) clearance on 2007-09-19, under 510(k) number K072364.

Who is the listed applicant for PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES?

The FDA 510(k) record lists Pulsion Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES?

The FDA product code for PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES is KRB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pulsion Medical Systems AG 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.

K091786PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)K072735PULSION PICCO-2, MODEL 8500K060898PULSION PICCO PLUS, MODEL 8100K020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda MedicalK915627PACEVIEWMicromedical Industries, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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