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FDA 510(k)

POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP

K-Number: K883016 · 1988-09-16

ApplicantCardiac Control Systems, Inc.
Decision Date1988-09-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP 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 1988-09-16 under 510(k) number K883016. 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 POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP?

POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K883016.

When did POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP receive FDA 510(k) clearance?

POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP received FDA 510(k) clearance on 1988-09-16, under 510(k) number K883016.

Who is the listed applicant for POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP?

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 POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP?

The FDA product code for POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP 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.

K971775INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKERK950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKERK923868CCS MAESTRO II SERIES 200 CARDIAC PACEMAKERK905824MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKEK904941MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE

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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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