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FDA 510(k)

SAFEWEDGE(TM) RELIEF VALVE DEVICE

K-Number: K912172 · 1991-09-27

ApplicantSunscope Intl., Inc.
Decision Date1991-09-27
Product CodeKRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFEWEDGE(TM) RELIEF VALVE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sunscope Intl., Inc.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K912172. The device is classified under product code KRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFEWEDGE(TM) RELIEF VALVE DEVICE?

SAFEWEDGE(TM) RELIEF VALVE DEVICE is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Sunscope Intl., Inc.. The 510(k) number is K912172.

When did SAFEWEDGE(TM) RELIEF VALVE DEVICE receive FDA 510(k) clearance?

SAFEWEDGE(TM) RELIEF VALVE DEVICE received FDA 510(k) clearance on 1991-09-27, under 510(k) number K912172.

Who is the listed applicant for SAFEWEDGE(TM) RELIEF VALVE DEVICE?

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

What is the FDA product code for SAFEWEDGE(TM) RELIEF VALVE DEVICE?

The FDA product code for SAFEWEDGE(TM) RELIEF VALVE DEVICE is KRB.

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Other records listing Sunscope Intl., 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.

K002786BIOSENSORS CENTRAL VENOUS CATHETER KITSK983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPK973477BIOSENSORS EMBOLECTOMY CATHETERK981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXK981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXK911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIES

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Related Devices (Code: KRB)

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.

K171620PiCCO CatheterPulsion Medical Systems SEK100739VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5Edwards Lifesciences, LLCK072364PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIESPulsion Medical Systems AGK020587PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046Pulsion Medical Systems AGK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITOhmeda Medical

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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