FDA 510(k)

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE

K-Number: K912545 · 1991-07-26

Decision Date1991-07-26

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K912545. 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 MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE?

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Pace Medical. The 510(k) number is K912545.

When did MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE receive FDA 510(k) clearance?

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912545.

Who is the listed applicant for MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE?

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

What is the FDA product code for MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE?

The FDA product code for MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE is DXY. This falls under the Clinical Chemistry category.

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Other records listing Pace Medical as applicant

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V K002497MODEL 4810 ANALYZER OUTPUT ADAPTER K002496MODEL 4815 ADAPTER K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

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Related Devices (Code: DXY)

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 Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX 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.