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FDA 510(k)

OMEGA NV(TM) BALLOON DILATATION CATHETER

K-Number: K882052 · 1988-09-14

ApplicantCook, Inc.
Decision Date1988-09-14
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMEGA NV(TM) 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 1988-09-14 under 510(k) number K882052. 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 OMEGA NV(TM) BALLOON DILATATION CATHETER?

OMEGA NV(TM) BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1988-09-14. The listed applicant is Cook, Inc.. The 510(k) number is K882052.

When did OMEGA NV(TM) BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

OMEGA NV(TM) BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1988-09-14, under 510(k) number K882052.

Who is the listed applicant for OMEGA NV(TM) 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 OMEGA NV(TM) BALLOON DILATATION CATHETER?

The FDA product code for OMEGA NV(TM) 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)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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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