FDA 510(k)

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015

K-Number: K990333 · 1999-04-28

Decision Date1999-04-28

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic PS Medical. It received FDA 510(k) clearance on 1999-04-28 under 510(k) number K990333. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015?

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 is a medical device that received FDA 510(k) clearance on 1999-04-28. The listed applicant is Medtronic PS Medical. The 510(k) number is K990333.

When did MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 receive FDA 510(k) clearance?

MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 received FDA 510(k) clearance on 1999-04-28, under 510(k) number K990333.

Who is the listed applicant for MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015?

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

What is the FDA product code for MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015?

The FDA product code for MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 is GWG.

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Other records listing Medtronic PS Medical as applicant

K012052MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 K010361MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 K010487BIPOLAR PENCIL, MODEL 3901-002, 3900-002 K010341MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,K003914MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES K002572MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005

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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.