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FDA 510(k)

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT

K-Number: K891411 · 1991-12-18

ApplicantCook, Inc.
Decision Date1991-12-18
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K891411. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT?

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Cook, Inc.. The 510(k) number is K891411.

When did GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT receive FDA 510(k) clearance?

GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT received FDA 510(k) clearance on 1991-12-18, under 510(k) number K891411.

Who is the listed applicant for GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT?

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 GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT?

The FDA product code for GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT is JCT.

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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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Related Devices (Code: JCT)

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.

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific CorporationK220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.

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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