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FDA 510(k)

LIVER TAMPONADE BALLOON

K-Number: K010450 · 2001-09-06

ApplicantCook, Inc.
Decision Date2001-09-06
Product CodeNGU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LIVER TAMPONADE BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K010450. The device is classified under product code NGU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIVER TAMPONADE BALLOON?

LIVER TAMPONADE BALLOON is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Cook, Inc.. The 510(k) number is K010450.

When did LIVER TAMPONADE BALLOON receive FDA 510(k) clearance?

LIVER TAMPONADE BALLOON received FDA 510(k) clearance on 2001-09-06, under 510(k) number K010450.

Who is the listed applicant for LIVER TAMPONADE BALLOON?

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

What is the FDA product code for LIVER TAMPONADE BALLOON?

The FDA product code for LIVER TAMPONADE BALLOON is NGU.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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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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