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FDA 510(k)

COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67

K-Number: K964821 · 1997-07-16

ApplicantVentrex, Inc.
Decision Date1997-07-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 is the device name listed in this FDA 510(k) record. The listed applicant is Ventrex, Inc.. It received FDA 510(k) clearance on 1997-07-16 under 510(k) number K964821. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67?

COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 is a medical device that received FDA 510(k) clearance on 1997-07-16. The listed applicant is Ventrex, Inc.. The 510(k) number is K964821.

When did COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 receive FDA 510(k) clearance?

COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 received FDA 510(k) clearance on 1997-07-16, under 510(k) number K964821.

Who is the listed applicant for COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67?

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

What is the FDA product code for COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67?

The FDA product code for COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 is DQA.

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Other records listing Ventrex, 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.

K061044FEATHERLITE AQUA TOCODYNAMOMETERK013477TOCO LITE, MODEL TD-01K925044VENTREX ALLERGEN DISCK924119VENTREX ALLERGEN DISC

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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