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FDA 510(k)

8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS

K-Number: K911122 · 1991-05-16

ApplicantIntermedics, Inc.
Decision Date1991-05-16
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1991-05-16 under 510(k) number K911122. 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 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS?

8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS is a medical device that received FDA 510(k) clearance on 1991-05-16. The listed applicant is Intermedics, Inc.. The 510(k) number is K911122.

When did 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS receive FDA 510(k) clearance?

8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS received FDA 510(k) clearance on 1991-05-16, under 510(k) number K911122.

Who is the listed applicant for 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS?

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

What is the FDA product code for 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS?

The FDA product code for 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS is DXY. This falls under the Clinical Chemistry category.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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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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