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FDA 510(k)

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER

K-Number: K920157 · 1992-03-16

ApplicantSchneider Intl., Ltd.
Decision Date1992-03-16
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Schneider Intl., Ltd.. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K920157. 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 SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER?

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is Schneider Intl., Ltd.. The 510(k) number is K920157.

When did SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER receive FDA 510(k) clearance?

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER received FDA 510(k) clearance on 1992-03-16, under 510(k) number K920157.

Who is the listed applicant for SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER?

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

What is the FDA product code for SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER?

The FDA product code for SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER is DXY. This falls under the Clinical Chemistry category.

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Other records listing Schneider Intl., Ltd. 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.

K925406BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEMK931577SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWIK926003SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETERK926271SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIOK925804SCHNEIDER HYDRO-SIL GUIDEWIREK924591SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER

View all 22 devices →

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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