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FDA 510(k)

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR

K-Number: K855049 · 1986-02-26

ApplicantScimed Life Systems, Inc.
Decision Date1986-02-26
Product CodeDTP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1986-02-26 under 510(k) number K855049. The device is classified under product code DTP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR?

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K855049.

When did MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855049.

Who is the listed applicant for MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR?

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

What is the FDA product code for MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR?

The FDA product code for MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR is DTP.

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Other records listing Scimed Life 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.

K974241SCIMED INFORMER PRESSURE WIRE SYSTEMK981788SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETERK980360SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRESK974559SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERSK974684SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETERK973945LUGE GUIDE WIRE

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Related Devices (Code: DTP)

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.

K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAGMedtronic Perfusion SystemsK082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160Mapquet Cardiopulmonary AGK004046COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.K990514MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VRC.R. Bard, Inc.K984322DIDECO D920, LILLIPUT 1 TWIN RESERVOIRDideco S.P.A.

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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