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FDA 510(k)

CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK

K-Number: K993619 · 2000-04-28

ApplicantSims Portex, Inc.
Decision Date2000-04-28
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K993619. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK?

CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Sims Portex, Inc.. The 510(k) number is K993619.

When did CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK receive FDA 510(k) clearance?

CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK received FDA 510(k) clearance on 2000-04-28, under 510(k) number K993619.

Who is the listed applicant for CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK?

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

What is the FDA product code for CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK?

The FDA product code for CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK is BSP.

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Other records listing Sims Portex, 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.

K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIOK002201ELECTROSTATIC HYDROPHOBIC BREATHING FILTERK002506BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUITK001318CPAP SYSTEM, MODEL 102001K994275SIMS PORTEX ANESTHESIA CATHETERK9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE

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Related Devices (Code: BSP)

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.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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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