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FDA 510(k)

REAL Immersive System

K-Number: K183296 · 2019-03-18

ApplicantPenumbra, Inc.
Decision Date2019-03-18
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REAL Immersive System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K183296. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL Immersive System?

REAL Immersive System is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Penumbra, Inc.. The 510(k) number is K183296.

When did REAL Immersive System receive FDA 510(k) clearance?

REAL Immersive System received FDA 510(k) clearance on 2019-03-18, under 510(k) number K183296.

Who is the listed applicant for REAL Immersive System?

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

What is the FDA product code for REAL Immersive System?

The FDA product code for REAL Immersive System is ISD.

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.

NCT04798261Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration SystemRECRUITINGNCT05003843BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein ThrombosisACTIVE_NOT_RECRUITINGNCT05437055THUNDER: Acute Ischemic Stroke Study With the Penumbra System® Including Thunderbolt™ Aspiration TubingCOMPLETEDNCT05684796Comparison of Two Pulmonary Embolism TreatmentsCOMPLETEDNCT06747117A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)RECRUITINGNCT07107022Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS).RECRUITING

Other records listing Penumbra, 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.

K250690Penumbra System (Thunderbolt Aspiration Tubing)K260599INDIGO® Aspiration System – INDIGO LinkK251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK250079Ruby XL SystemK242104Penumbra System (Reperfusion Catheter RED 72)

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Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.

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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