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FDA 510(k)

INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM

K-Number: K885154 · 1989-02-22

ApplicantMedtronic Blood Systems, Inc.
Decision Date1989-02-22
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Systems, Inc.. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K885154. The device is classified under product code KRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM?

INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K885154.

When did INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM receive FDA 510(k) clearance?

INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM received FDA 510(k) clearance on 1989-02-22, under 510(k) number K885154.

Who is the listed applicant for INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM?

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

What is the FDA product code for INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM?

The FDA product code for INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM is KRJ.

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Other records listing Medtronic Blood Systems, 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.

K944966UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492K944957TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500K893207CLOSED CHEST SUPPORT CIRCUITK893678DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601HK891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEK891230MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

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Related Devices (Code: KRJ)

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.

K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.K884244INTERSEPT* PREBYPASS FILTERMedtronic Blood Systems, Inc.

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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