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FDA 510(k)

CVD BULLET INFUSION CATYHETER

K-Number: K951502 · 1995-05-10

ApplicantCardiovascular Dynamics, Inc.
Decision Date1995-05-10
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CVD BULLET INFUSION CATYHETER 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 1995-05-10 under 510(k) number K951502. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVD BULLET INFUSION CATYHETER?

CVD BULLET INFUSION CATYHETER is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Cardiovascular Dynamics, Inc.. The 510(k) number is K951502.

When did CVD BULLET INFUSION CATYHETER receive FDA 510(k) clearance?

CVD BULLET INFUSION CATYHETER received FDA 510(k) clearance on 1995-05-10, under 510(k) number K951502.

Who is the listed applicant for CVD BULLET INFUSION CATYHETER?

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 CVD BULLET INFUSION CATYHETER?

The FDA product code for CVD BULLET INFUSION CATYHETER is KRA.

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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.

K97371322 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CARK971577FOCUS-PV BALLOON DILATATION CATHETERK963989P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICEK963688FOCUS PV BALLOON DILATATION CATHETERK945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETERK952064FOCUS BALLOON DILATATION CATHETER

View all 11 devices →

Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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