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FDA 510(k)

SAF-D-FIB

K-Number: K852469 · 1985-09-16

ApplicantMedtronic Andover Medical, Inc.
Decision Date1985-09-16
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAF-D-FIB is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Andover Medical, Inc.. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K852469. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAF-D-FIB?

SAF-D-FIB is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Medtronic Andover Medical, Inc.. The 510(k) number is K852469.

When did SAF-D-FIB receive FDA 510(k) clearance?

SAF-D-FIB received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852469.

Who is the listed applicant for SAF-D-FIB?

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

What is the FDA product code for SAF-D-FIB?

The FDA product code for SAF-D-FIB is DRX.

Other records listing Medtronic Andover Medical, 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.

K910494RESTING EKG ELECTRODE SERIESK905446MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODEK903018MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002K903554NORTECH MODEL 87202204 ELECTRODEK882174MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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