FDA 510(k)

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

K-Number: K012489 · 2001-08-30

Decision Date2001-08-30

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 is the device name listed in this FDA 510(k) record. The listed applicant is Appriva Medical, Inc.. It received FDA 510(k) clearance on 2001-08-30 under 510(k) number K012489. 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 MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10?

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 is a medical device that received FDA 510(k) clearance on 2001-08-30. The listed applicant is Appriva Medical, Inc.. The 510(k) number is K012489.

When did MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 receive FDA 510(k) clearance?

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 received FDA 510(k) clearance on 2001-08-30, under 510(k) number K012489.

Who is the listed applicant for MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10?

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

What is the FDA product code for MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10?

The FDA product code for MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 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 Appriva Medical, Inc. as applicant

K002054X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1

Related Devices (Code: DYB)

K253526NAMIC Dilator and SheathMedline Industries, LP K261529Micropuncture 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, LLC K261242SimplGuidePendracare K261950Health Line Tearaway IntroducerHealth Line International Corporation K261492FieldFlex Steerable SheathCenterPoint Systems, LLC K260606Echo 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.