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FDA 510(k)

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

K-Number: K925661 · 1993-05-18

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1993-05-18
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1993-05-18 under 510(k) number K925661. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE?

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1993-05-18. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K925661.

When did STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE receive FDA 510(k) clearance?

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE received FDA 510(k) clearance on 1993-05-18, under 510(k) number K925661.

Who is the listed applicant for STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE?

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

What is the FDA product code for STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE?

The FDA product code for STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE is KRL.

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Other records listing Sorin Biomedica, Fiat, USA, 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.

K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORSK925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEK925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSK924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORK925541STOCKERT 1/4 BUBBLE SENSORK922933SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

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Related Devices (Code: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, Sarns

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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