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FDA 510(k)

PTI HEART-CHILL POUCH/PAD SLING (STERILE)

K-Number: K873924 · 1988-02-02

ApplicantBuckman Co., Inc.
Decision Date1988-02-02
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI HEART-CHILL POUCH/PAD 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 1988-02-02 under 510(k) number K873924. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI HEART-CHILL POUCH/PAD SLING (STERILE)?

PTI HEART-CHILL POUCH/PAD SLING (STERILE) is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Buckman Co., Inc.. The 510(k) number is K873924.

When did PTI HEART-CHILL POUCH/PAD SLING (STERILE) receive FDA 510(k) clearance?

PTI HEART-CHILL POUCH/PAD SLING (STERILE) received FDA 510(k) clearance on 1988-02-02, under 510(k) number K873924.

Who is the listed applicant for PTI HEART-CHILL POUCH/PAD 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-CHILL POUCH/PAD SLING (STERILE)?

The FDA product code for PTI HEART-CHILL POUCH/PAD SLING (STERILE) is DWC.

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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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