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FDA 510(k)

DIRECTIONAL BOOT

K-Number: K813150 · 1981-12-02

ApplicantPacesetter Systems
Decision Date1981-12-02
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIRECTIONAL BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K813150. 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 DIRECTIONAL BOOT?

DIRECTIONAL BOOT is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Pacesetter Systems. The 510(k) number is K813150.

When did DIRECTIONAL BOOT receive FDA 510(k) clearance?

DIRECTIONAL BOOT received FDA 510(k) clearance on 1981-12-02, under 510(k) number K813150.

Who is the listed applicant for DIRECTIONAL BOOT?

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

What is the FDA product code for DIRECTIONAL BOOT?

The FDA product code for DIRECTIONAL BOOT is DXY. This falls under the Clinical Chemistry category.

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Other records listing Pacesetter Systems 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.

K910924ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONEK902147ENDOCARDIAL SCREW-IN LEAD MODEL 1028TK900512SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERSK900550FAST-PASS ACE MODELS 1212T/1222T/1216T/1226TK895447ENDOCARDIAL SCREW-IN LEAD MODEL 1020TK891905CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

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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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