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FDA 510(k)

BERMAN ANGIOGRAPHIC BALLOON CATHETER

K-Number: K822033 · 1982-08-24

ApplicantZiehm International, Inc.
Decision Date1982-08-24
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BERMAN ANGIOGRAPHIC BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K822033. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERMAN ANGIOGRAPHIC BALLOON CATHETER?

BERMAN ANGIOGRAPHIC BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Ziehm International, Inc.. The 510(k) number is K822033.

When did BERMAN ANGIOGRAPHIC BALLOON CATHETER receive FDA 510(k) clearance?

BERMAN ANGIOGRAPHIC BALLOON CATHETER received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822033.

Who is the listed applicant for BERMAN ANGIOGRAPHIC BALLOON CATHETER?

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

What is the FDA product code for BERMAN ANGIOGRAPHIC BALLOON CATHETER?

The FDA product code for BERMAN ANGIOGRAPHIC BALLOON CATHETER is DQO.

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Other records listing Ziehm International, 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.

K011292ZIEHM VISIONK910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK890620STICK-GARD SAFETY NEEDLE

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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