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FDA 510(k)

SOFTIP CATHETER

K-Number: K834275 · 1984-02-04

ApplicantAngiomedics, Inc.
Decision Date1984-02-04
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOFTIP CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Angiomedics, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834275. 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 SOFTIP CATHETER?

SOFTIP CATHETER is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Angiomedics, Inc.. The 510(k) number is K834275.

When did SOFTIP CATHETER receive FDA 510(k) clearance?

SOFTIP CATHETER received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834275.

Who is the listed applicant for SOFTIP CATHETER?

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

What is the FDA product code for SOFTIP CATHETER?

The FDA product code for SOFTIP CATHETER is DQO.

Related Clinical Trials

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.

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Other records listing Angiomedics, 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.

K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMOK872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICEK872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETERK863342SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETERK861238ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALVK852872ANGIOMEDICS SOFTIP CATHETER

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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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