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FDA 510(k)

MEDTRONIC 5311 PACING SYSTEM ANALYZER

K-Number: K850077 · 1985-07-16

ApplicantMedtronic Vascular
Decision Date1985-07-16
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC 5311 PACING SYSTEM ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1985-07-16 under 510(k) number K850077. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC 5311 PACING SYSTEM ANALYZER?

MEDTRONIC 5311 PACING SYSTEM ANALYZER is a medical device that received FDA 510(k) clearance on 1985-07-16. The listed applicant is Medtronic Vascular. The 510(k) number is K850077.

When did MEDTRONIC 5311 PACING SYSTEM ANALYZER receive FDA 510(k) clearance?

MEDTRONIC 5311 PACING SYSTEM ANALYZER received FDA 510(k) clearance on 1985-07-16, under 510(k) number K850077.

Who is the listed applicant for MEDTRONIC 5311 PACING SYSTEM ANALYZER?

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

What is the FDA product code for MEDTRONIC 5311 PACING SYSTEM ANALYZER?

The FDA product code for MEDTRONIC 5311 PACING SYSTEM ANALYZER is DTC.

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Other records listing Medtronic Vascular as applicant

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K232570Steerant™ Super Stiff GuidewireK2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterK2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide CatheterK220773Everest 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)K192296Medtronic 6F Taiga Guiding CatheterK173515Admiral Xtreme

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Related Devices (Code: DTC)

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.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, 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.

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