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FDA 510(k)

TRANSVENOUS BALLOON CATH. INTRO. KIT

K-Number: K792130 · 1979-11-13

ApplicantStanco Medical, Inc.
Decision Date1979-11-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSVENOUS BALLOON CATH. INTRO. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Stanco Medical, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792130. 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 TRANSVENOUS BALLOON CATH. INTRO. KIT?

TRANSVENOUS BALLOON CATH. INTRO. KIT is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Stanco Medical, Inc.. The 510(k) number is K792130.

When did TRANSVENOUS BALLOON CATH. INTRO. KIT receive FDA 510(k) clearance?

TRANSVENOUS BALLOON CATH. INTRO. KIT received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792130.

Who is the listed applicant for TRANSVENOUS BALLOON CATH. INTRO. KIT?

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

What is the FDA product code for TRANSVENOUS BALLOON CATH. INTRO. KIT?

The FDA product code for TRANSVENOUS BALLOON CATH. INTRO. KIT is DYB.

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Other records listing Stanco Medical, 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.

K810643UNIVERSAL PACING ELECTRODE KITK810642ATRIAL-VENTRICULAR PACING ELECTRODE KITK802289PERICARDIOCENTESIS KITK802288SWAN GANZ CATHETER PLACEMENT KITK802287RIGHT ATRIAL LINE KITK802259TRANSVENOUS PACEMAKER ELECTRODE KIT

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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

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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