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FDA 510(k)

MECONIUM SUCTION TRAP

K-Number: K862181 · 1986-08-13

ApplicantMichael Reese Hospital and Medical Center
Decision Date1986-08-13
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MECONIUM SUCTION TRAP is the device name listed in this FDA 510(k) record. The listed applicant is Michael Reese Hospital and Medical Center. It received FDA 510(k) clearance on 1986-08-13 under 510(k) number K862181. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECONIUM SUCTION TRAP?

MECONIUM SUCTION TRAP is a medical device that received FDA 510(k) clearance on 1986-08-13. The listed applicant is Michael Reese Hospital and Medical Center. The 510(k) number is K862181.

When did MECONIUM SUCTION TRAP receive FDA 510(k) clearance?

MECONIUM SUCTION TRAP received FDA 510(k) clearance on 1986-08-13, under 510(k) number K862181.

Who is the listed applicant for MECONIUM SUCTION TRAP?

The FDA 510(k) record lists Michael Reese Hospital and Medical Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECONIUM SUCTION TRAP?

The FDA product code for MECONIUM SUCTION TRAP is BSY.

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 Michael Reese Hospital and Medical Center 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.

K862182AMNIOINFUSION CATHETER

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

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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