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FDA 510(k)

AUGUSTINE GUIDE(TM) KIT

K-Number: K912690 · 1991-09-04

ApplicantAugustine Medical, Inc.
Decision Date1991-09-04
Product CodeBSR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUGUSTINE GUIDE(TM) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Medical, Inc.. It received FDA 510(k) clearance on 1991-09-04 under 510(k) number K912690. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUGUSTINE GUIDE(TM) KIT?

AUGUSTINE GUIDE(TM) KIT is a medical device that received FDA 510(k) clearance on 1991-09-04. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K912690.

When did AUGUSTINE GUIDE(TM) KIT receive FDA 510(k) clearance?

AUGUSTINE GUIDE(TM) KIT received FDA 510(k) clearance on 1991-09-04, under 510(k) number K912690.

Who is the listed applicant for AUGUSTINE GUIDE(TM) KIT?

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

What is the FDA product code for AUGUSTINE GUIDE(TM) KIT?

The FDA product code for AUGUSTINE GUIDE(TM) KIT is BSR.

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Other records listing Augustine 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.

K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMK020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXK001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANKK973741BAIR HUGGER BLOOD/FLUID WARMERK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

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Related Devices (Code: BSR)

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.

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook IncorporatedK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales Intl., 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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