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FDA 510(k)

DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)

K-Number: K870215 · 1987-08-12

ApplicantCook, Inc.
Decision Date1987-08-12
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K870215. 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 DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)?

DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Cook, Inc.. The 510(k) number is K870215.

When did DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) receive FDA 510(k) clearance?

DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) received FDA 510(k) clearance on 1987-08-12, under 510(k) number K870215.

Who is the listed applicant for DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)?

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 DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)?

The FDA product code for DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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