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FDA 510(k)

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)

K-Number: K853136 · 1985-12-03

ApplicantE.A. Fischione Instrument Mfg.
Decision Date1985-12-03
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) is the device name listed in this FDA 510(k) record. The listed applicant is E.A. Fischione Instrument Mfg.. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K853136. 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 MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)?

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is E.A. Fischione Instrument Mfg.. The 510(k) number is K853136.

When did MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) receive FDA 510(k) clearance?

MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) received FDA 510(k) clearance on 1985-12-03, under 510(k) number K853136.

Who is the listed applicant for MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)?

The FDA 510(k) record lists E.A. Fischione Instrument Mfg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)?

The FDA product code for MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) 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.

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Other records listing E.A. Fischione Instrument Mfg. 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.

K841493MODEL 1000 APC-ANGIOPLASTY PRESSURE

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

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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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