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FDA 510(k)

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.

K-Number: K800030 · 1980-01-11

ApplicantTelectronics, Inc.
Decision Date1980-01-11
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1980-01-11 under 510(k) number K800030. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.?

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. is a medical device that received FDA 510(k) clearance on 1980-01-11. The listed applicant is Telectronics, Inc.. The 510(k) number is K800030.

When did IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. receive FDA 510(k) clearance?

IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. received FDA 510(k) clearance on 1980-01-11, under 510(k) number K800030.

Who is the listed applicant for IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.?

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

What is the FDA product code for IMPLANTABLE BIPOLAR CARDIAC PULSE GEN.?

The FDA product code for IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. is DXY. This falls under the Clinical Chemistry category.

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Other records listing Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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Related Devices (Code: DXY)

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.

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

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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