Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aspira Peritoneal Drainage System

K-Number: K212675 · 2021-12-14

ApplicantMerit Medical Systems, Inc.
Decision Date2021-12-14
Product CodePNG
Advisory CommitteeGU
DecisionUnknown

Device Summary

Aspira Peritoneal Drainage System is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212675. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Aspira Peritoneal Drainage System?

Aspira Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K212675.

When did Aspira Peritoneal Drainage System receive FDA 510(k) clearance?

Aspira Peritoneal Drainage System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212675.

Who is the listed applicant for Aspira Peritoneal Drainage System?

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

What is the FDA product code for Aspira Peritoneal Drainage System?

The FDA product code for Aspira Peritoneal Drainage System is PNG.

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.

NCT03311451C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.ACTIVE_NOT_RECRUITINGNCT04540302The Merit WRAPSODY AV Access Efficacy Study (WAVE)COMPLETEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT06153667Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)RECRUITINGNCT06422871PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on HemodialysisRECRUITINGNCT06587282PREEMIE: Study for Treatment of PDA in Premature InfantsACTIVE_NOT_RECRUITING

Other records listing Merit Medical Systems, 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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetK262086PreludeSYNC™ Radial Compression DevicePMA P240023System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentK254073StatSeal DiscK251802STAR RF Ablation SystemK252892SCOUT MD Surgical Guidance System

View all 68 devices →

Related Devices (Code: PNG)

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.

K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc.K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-Bard Peripheral Vascular, Inc.K230319Passio Pump Drainage SystemBearpac MedicalK221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.K201155PleurX Peritoneal Catheter SystemCare FusionK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc

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.

↑