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FDA 510(k)

GUIDING CATHETER (TIP SOFTNESS CHANGE)

K-Number: K883981 · 1988-11-03

ApplicantDevices For Vascular Intervention, Inc.
Decision Date1988-11-03
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDING CATHETER (TIP SOFTNESS CHANGE) is the device name listed in this FDA 510(k) record. The listed applicant is Devices For Vascular Intervention, Inc.. It received FDA 510(k) clearance on 1988-11-03 under 510(k) number K883981. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDING CATHETER (TIP SOFTNESS CHANGE)?

GUIDING CATHETER (TIP SOFTNESS CHANGE) is a medical device that received FDA 510(k) clearance on 1988-11-03. The listed applicant is Devices For Vascular Intervention, Inc.. The 510(k) number is K883981.

When did GUIDING CATHETER (TIP SOFTNESS CHANGE) receive FDA 510(k) clearance?

GUIDING CATHETER (TIP SOFTNESS CHANGE) received FDA 510(k) clearance on 1988-11-03, under 510(k) number K883981.

Who is the listed applicant for GUIDING CATHETER (TIP SOFTNESS CHANGE)?

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

What is the FDA product code for GUIDING CATHETER (TIP SOFTNESS CHANGE)?

The FDA product code for GUIDING CATHETER (TIP SOFTNESS CHANGE) is DWF.

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 Devices For Vascular Intervention, 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.

K935929MICROTRACKK920707HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLERK914422DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVEK911678ROTATING HEMOSTATIC VALVEK910205LP-60 LOW PRESSURE INFLATION DEVICEK901601HOLLOW MOTOR DRIVE UNIT

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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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