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FDA 510(k)

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR

K-Number: K973713 · 1998-01-23

ApplicantCardiovascular Dynamics, Inc.
Decision Date1998-01-23
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Dynamics, Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K973713. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR?

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Cardiovascular Dynamics, Inc.. The 510(k) number is K973713.

When did 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR receive FDA 510(k) clearance?

22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR received FDA 510(k) clearance on 1998-01-23, under 510(k) number K973713.

Who is the listed applicant for 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR?

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

What is the FDA product code for 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR?

The FDA product code for 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR is ITX.

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Other records listing Cardiovascular Dynamics, 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.

K971577FOCUS-PV BALLOON DILATATION CATHETERK963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICEK963688FOCUS PV BALLOON DILATATION CATHETERK945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETERK952064FOCUS BALLOON DILATATION CATHETERK951502CVD BULLET INFUSION CATYHETER

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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