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)

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500

K-Number: K903503 · 1990-10-09

ApplicantScimed
Decision Date1990-10-09
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 is the device name listed in this FDA 510(k) record. The listed applicant is Scimed. It received FDA 510(k) clearance on 1990-10-09 under 510(k) number K903503. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED ENCORE INFLATION DEVICE, MODEL SM2500?

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 is a medical device that received FDA 510(k) clearance on 1990-10-09. The listed applicant is Scimed. The 510(k) number is K903503.

When did SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 receive FDA 510(k) clearance?

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 received FDA 510(k) clearance on 1990-10-09, under 510(k) number K903503.

Who is the listed applicant for SCIMED ENCORE INFLATION DEVICE, MODEL SM2500?

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

What is the FDA product code for SCIMED ENCORE INFLATION DEVICE, MODEL SM2500?

The FDA product code for SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 is MAV.

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 Scimed 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.

K992142SCIMED ANGIOGRAPHIC CATHETERSK953909SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETERK931584SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.K922706SCIMED SIDELINERK915347SCIMED VIPER CATHETERK9109877FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

View all 8 devices →

Related Devices (Code: MAV)

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.

K260035Digital Indeflator INFLANTEUAB TelemedicinaK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, 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.

↑