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FDA 510(k)

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

K-Number: K964445 · 1997-01-30

ApplicantDlp, Inc.
Decision Date1997-01-30
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) is the device name listed in this FDA 510(k) record. The listed applicant is Dlp, Inc.. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964445. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)?

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Dlp, Inc.. The 510(k) number is K964445.

When did OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) receive FDA 510(k) clearance?

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964445.

Who is the listed applicant for OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)?

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

What is the FDA product code for OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)?

The FDA product code for OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) is DWS.

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Other records listing Dlp, 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.

K973485CLEARVIEW BLOWER/MISTERK953945RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLETK950754MACRO SUCTION TUBE MODEL NO 10061K934215CONTAIN-ORK915268CATHETER TWO STAGE VENOUS RETURNK914608BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120

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Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical SystemsK960143G.E. STERILE DIGITAL ANGIOGRAPHIC TRAYGE Medical Systems

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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