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FDA 510(k)

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

K-Number: K040552 · 2004-05-28

ApplicantCryocor, Inc.
Decision Date2004-05-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 is the device name listed in this FDA 510(k) record. The listed applicant is Cryocor, Inc.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K040552. 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 MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130?

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Cryocor, Inc.. The 510(k) number is K040552.

When did MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 receive FDA 510(k) clearance?

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040552.

Who is the listed applicant for MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130?

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

What is the FDA product code for MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130?

The FDA product code for MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 is DYB.

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Other records listing Cryocor, 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.

K041890CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12

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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