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FDA 510(k)

CCS MODEL SJ-103 IMPLANTABLE ATRIAL

K-Number: K831529 · 1983-06-30

ApplicantCardiac Control Systems, Inc.
Decision Date1983-06-30
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CCS MODEL SJ-103 IMPLANTABLE ATRIAL is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Control Systems, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831529. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CCS MODEL SJ-103 IMPLANTABLE ATRIAL?

CCS MODEL SJ-103 IMPLANTABLE ATRIAL is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K831529.

When did CCS MODEL SJ-103 IMPLANTABLE ATRIAL receive FDA 510(k) clearance?

CCS MODEL SJ-103 IMPLANTABLE ATRIAL received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831529.

Who is the listed applicant for CCS MODEL SJ-103 IMPLANTABLE ATRIAL?

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

What is the FDA product code for CCS MODEL SJ-103 IMPLANTABLE ATRIAL?

The FDA product code for CCS MODEL SJ-103 IMPLANTABLE ATRIAL is DTB.

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Other records listing Cardiac Control Systems, 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.

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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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