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FDA 510(k)

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)

K-Number: K972017 · 1997-09-10

ApplicantMinntech Corp.
Decision Date1997-09-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K972017. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)?

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Minntech Corp.. The 510(k) number is K972017.

When did BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) receive FDA 510(k) clearance?

BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) received FDA 510(k) clearance on 1997-09-10, under 510(k) number K972017.

Who is the listed applicant for BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)?

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

What is the FDA product code for BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)?

The FDA product code for BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) is DTN.

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Other records listing Minntech Corp. 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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Related Devices (Code: DTN)

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.

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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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