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FDA 510(k)

MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD

K-Number: K851458 · 1985-07-11

ApplicantIntermedics, Inc.
Decision Date1985-07-11
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1985-07-11 under 510(k) number K851458. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD?

MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD is a medical device that received FDA 510(k) clearance on 1985-07-11. The listed applicant is Intermedics, Inc.. The 510(k) number is K851458.

When did MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD receive FDA 510(k) clearance?

MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD received FDA 510(k) clearance on 1985-07-11, under 510(k) number K851458.

Who is the listed applicant for MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD?

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

What is the FDA product code for MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD?

The FDA product code for MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD is DTD.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 devices →

Related Devices (Code: DTD)

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.

K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant CorporationK031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, 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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