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FDA 510(k)

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

K-Number: K881825 · 1988-09-28

ApplicantSpectramed, Inc.
Decision Date1988-09-28
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1988-09-28 under 510(k) number K881825. 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 MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH?

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH is a medical device that received FDA 510(k) clearance on 1988-09-28. The listed applicant is Spectramed, Inc.. The 510(k) number is K881825.

When did MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH receive FDA 510(k) clearance?

MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH received FDA 510(k) clearance on 1988-09-28, under 510(k) number K881825.

Who is the listed applicant for MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH?

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

What is the FDA product code for MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH?

The FDA product code for MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH is DYB.

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Other records listing Spectramed, 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

View all 13 devices →

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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