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FDA 510(k)

NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE

K-Number: K942977 · 1995-12-28

ApplicantNovoste Corp.
Decision Date1995-12-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Novoste Corp.. It received FDA 510(k) clearance on 1995-12-28 under 510(k) number K942977. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE?

NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Novoste Corp.. The 510(k) number is K942977.

When did NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE receive FDA 510(k) clearance?

NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE received FDA 510(k) clearance on 1995-12-28, under 510(k) number K942977.

Who is the listed applicant for NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE?

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

What is the FDA product code for NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE?

The FDA product code for NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE is DYB.

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 Novoste Corp. 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.

K911527NOVOSTE GUIDING CATHETERK900460MODIFIED NOVOSTE ANGIOGRAPHIC CATHETERK896690MODIFIED ANGIOGRAPHIC CATHETERK875127NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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