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FDA 510(k)

ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER

K-Number: K130293 · 2013-05-31

ApplicantCook, Inc.
Decision Date2013-05-31
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2013-05-31 under 510(k) number K130293. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER?

ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-31. The listed applicant is Cook, Inc.. The 510(k) number is K130293.

When did ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2013-05-31, under 510(k) number K130293.

Who is the listed applicant for ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER?

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 ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER?

The FDA product code for ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER is LIT.

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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: LIT)

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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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