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FDA 510(k)

PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)

K-Number: K881717 · 1988-07-05

ApplicantBuckman Co., Inc.
Decision Date1988-07-05
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Buckman Co., Inc.. It received FDA 510(k) clearance on 1988-07-05 under 510(k) number K881717. 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 PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)?

PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) is a medical device that received FDA 510(k) clearance on 1988-07-05. The listed applicant is Buckman Co., Inc.. The 510(k) number is K881717.

When did PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) receive FDA 510(k) clearance?

PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) received FDA 510(k) clearance on 1988-07-05, under 510(k) number K881717.

Who is the listed applicant for PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)?

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

What is the FDA product code for PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)?

The FDA product code for PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE) is DWS.

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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 VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE 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 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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